[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Proposed Rules]
[Pages 12147-12169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05822]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1000, 1002, 1010, 1020, 1040, and 1050

[Docket No. FDA-2018-N-3303]
RIN 0910-AH65


Radiological Health Regulations; Amendments to Records and 
Reports for Radiation Emitting Electronic Products; Amendments to 
Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA, Agency, or we) is 
proposing to amend and repeal parts of the radiological health 
regulations covering recommendations for radiation protection during 
medical procedures, certain records and reporting for electronic 
products, and performance standards for diagnostic x-ray systems and 
their major components, laser products, and ultrasonic therapy 
products. The Agency is proposing this action to clarify and update the 
regulations to reduce regulatory requirements that are outdated and 
duplicate other means to better protect the public health against 
harmful exposure to radiation emitting electronic products and medical 
devices. This action is part of FDA's implementation of Executive 
Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively 
reviewing existing regulations to identify opportunities for repealing 
and amending regulations that will result in meaningful burden 
reduction while allowing the Agency to achieve our public health 
mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on this proposed 
rule by July 1, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 1, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3303 for ``Radiological Health Regulations; Amendments to 
Records and Reports for Radiation Emitting Electronic Products; 
Amendments to

[[Page 12148]]

Performance Standards for Diagnostic X-ray, Laser and Ultrasonic 
Products.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert Ochs, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993, 301-796-6661, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of Major Provisions
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. FDA's Current Statutory Authority Framework
    C. Need for Amendments to the Regulations
IV. Legal Authority
V. Description of the Proposed Rule
    A. Scope
    B. Proposed Repeal of Radiation Protection Recommendations
    C. Proposed Amendments About Applications for Variances
    D. Proposed Amendments About Records and Reports
    E. Proposed Amendments About Diagnostic X-ray Systems and Their 
Major Components
    F. Proposed Amendments About Laser Products
    G. Proposed Repeal of Ultrasonic Therapy Products Performance 
Standard
VI. Proposed Effective Date
VII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
    C. Summary of Regulatory Flexibility Analysis
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed rule would amend and repeal certain regulations for 
radiation emitting electronic products and medical devices because FDA 
has identified the regulations as being outdated and duplicative of 
other means for reducing radiation exposure to the public. The Agency 
is proposing to update the regulations to reduce regulations that are 
outdated and otherwise clarify requirements for protecting the public 
health against radiation exposure from specific electronic products and 
medical devices. The regulations being proposed for amending or 
repealing are the radiation protection recommendations for specific 
uses, records and reporting requirements for electronic products, 
applications for variances, and performance standards for diagnostic x-
ray systems and their major components, laser products, and ultrasonic 
therapy products.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule, when finalized, will update FDA's radiological 
health regulations to amend or repeal the following radiological health 
(21 CFR parts 1000 to 1050) parts of the general provisions:
     Repeal the radiation protection recommendations that have 
become outdated and unnecessary due to current FDA safety 
communications and other mechanisms that can provide more comprehensive 
recommendations to protect patients and health professionals from 
unnecessary radiation exposure;
     Amend the records and reporting requirements for 
electronic products and medical devices by removing or reducing some of 
the annual reports and test record requirements that are unnecessary or 
may be duplicative of other reporting requirements by FDA and State 
regulators;
     Revise the timing for submissions of reporting 
requirements for accidental radiation occurrences (AROs) to allow 
quarterly reporting for AROs that are not associated with a death or 
serious injury;
     Amend the applications for variances process to no longer 
require a manufacturer to submit two additional copies with the 
original documents;
     Amend the regulations to no longer require assemblers who 
install certified components of diagnostic x-ray systems to submit 
reports of assembly to the Agency. FDA is proposing to amend the 
regulations to require assemblers to submit assembly reports only to 
the purchaser, and, where applicable, to State agencies responsible for 
radiation protection because the Agency no longer uses the reports to 
plan routine inspections of newly assembled equipment;
     Amend the performance standard for laser products by 
reducing the regulatory requirements for: (1) Uncertified laser 
products that are intended to be used as a component and are 
incorporated into an electronic product that is then certified by the 
manufacturer of a finished electronic product and (2) certified and 
unmodified laser products that are not intended for use as a component 
or replacement and that are incorporated into another product; and
     Repeal the performance standards for sonic, infrasonic, 
and ultrasonic products because they are limited to a subset of 
physical therapy devices with an outdated standard. The Agency 
considers the premarket medical device regulations to be sufficient to 
ensure the

[[Page 12149]]

safety of ultrasonic therapy products. The current Electronic Product 
Radiation Control (EPRC) reporting for initial, abbreviated, and annual 
reports of ultrasonic products is also duplicative given the more 
comprehensive medical device regulations and premarket authorizations 
for these products.
    The Agency believes the amendments in this proposed rule will help 
ensure that the requirements for radiation emitting electronic products 
and devices will continue to protect the public health and safety while 
reducing regulatory burdens.

C. Legal Authority

    FDA is issuing this proposed rule under the same authority under 
which FDA initially issued these regulations, the device and general 
administrative provisions of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 321, 351, 352, 360, 360e-360j, 360hh-360ss, 371, 
374, and 381). FDA has the authority under section 534 of the FD&C Act 
(21 U.S.C. 360kk) to amend the performance standard for diagnostic x-
ray systems and their major components, amend the performance standard 
for laser products, and repeal radiation protection recommendations and 
the performance standard for ultrasonic therapy products, as provided 
for in this proposed rule.

D. Costs and Benefits

    This proposed rule will update FDA's radiological health 
regulations by amending parts of the general provisions including 
records and reporting requirements for electronic products. Benefits 
are estimated in terms of cost savings. Industry cost savings are 
derived by estimating the savings in reduced labor resulting from the 
reduction in reporting, recordkeeping, and third-party disclosure 
requirements. Cost savings to FDA result from the reduction in labor 
hours required to review reports. The total present value cost savings 
over a 20-year time period are $62.8 million at a 7 percent discount 
rate and $88.2 million at a 3 percent discount rate. Annualized total 
cost savings are $5.93 million. We estimate the costs to read the rule 
for all reporting respondents. The present value costs are $1.47 
million and the annualized costs calculated over a 20-year time period 
are $0.14 million at a 7 percent discount rate and $0.10 million at a 3 
percent discount rate.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

 
 
 
Accidental Radiation Occurrences.....  ARO
Center for Devices and Radiological    CDRH
 Health.
Centers for Medicare & Medicaid        CMS
 Services.
Conference of Radiation Control        CRCPD
 Program Directors.
Executive Order......................  EO
Electronic Product Radiation Control.  EPRC
Environmental Protection Agency......  EPA
Federal Food, Drug, and Cosmetic Act.  FD&C Act
Food and Drug Administration.........  FDA, Agency or we
International Commission on            ICRP
 Radiological Protection.
International Electrotechnical         IEC
 Commission.
Medical Device Reporting.............  MDR
National Council on Radiation          NCRP
 Protection and Measurements.
Radiation Control for Health and       RCHSA
 Safety Act.
Quality Assurance....................  QA
Technical Electronic Product           TEPRSSC
 Radiation Safety Standards Committee.
 

III. Background

A. Introduction

    Pursuant to EOs 13771 and 13777 (Refs. 1-2), FDA has conducted a 
comprehensive review of the requirements and recommendation of 
electronic products based on their level of radiation exposure. FDA 
recognizes that some records and reporting requirements for some 
radiation emitting electronic products and medical devices are not 
necessary to protect the public health and safety in compliance with 
the EPRC program (see sections 532, 534(a)(1), and 537(b) of the FD&C 
Act; 21 U.S.C. 360ii, 360kk(a)(1), and 360nn(b)). In addition, some of 
the recommended protections against radiation and performance standards 
are now outdated and redundant to other Federal and State requirements 
as practitioners and industry rely on numerous current radiation 
guidance documents, along with industry standards, to ensure the public 
health. For example, FDA recognizes that submission of quarterly 
reports is unnecessary given certain annual reporting requirements. The 
submission of initial product reports for products that are also 
subject to premarket authorization prior to marketing is duplicative. 
The recommended protections against radiation are now outdated and 
redundant to other Federal and State requirements and professional 
guidelines that apply to the education and licensing of practitioners 
(Refs. 3-7). Also, there are more recent standards that industry and 
FDA can rely on for the safety of ultrasonic therapy devices for 
physical medicine, for instance the International Electrotechnical 
Commission (IEC) standards 60601-2-5 and 61689.
    In addition, in the Federal Register of September 8, 2017 (82 FR 
42494), FDA published a notice for request for comments and information 
on the ``Review of Existing Center for Devices and Radiological Health 
Regulatory and Information Collection Requirements'' that could be 
amended, repealed or replaced to achieve meaningful burden reduction 
while achieving FDA's public health mission. FDA received comments 
regarding the radiological health regulations and its performance 
standards. As a result, FDA is proposing to amend its regulations for 
requirements for certain reporting and records of electronic products 
by removing or reducing certain reporting, as well as repealing 
outdated recommendations for radiation protection and performance 
standards, to alleviate regulatory burden to both FDA and industry.

B. FDA's Current Statutory Framework

    The FD&C Act (21 U.S.C. 301 et seq.), as amended, establishes a 
comprehensive system for the regulation of devices intended for human 
use.
    The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on 
November 28, 1990, transferred the provisions of the Radiation Control 
for Health and Safety Act of 1968 (Pub. L. 90-602) (formerly 42 U.S.C. 
263b through n(i) et seq.) from Title III of the Public Health Service 
Act to Chapter V, subchapter C of the FD&C Act, entitled ``Electronic 
Product Radiation Control'' (21 U.S.C. 360hh-360ss). Under these 
provisions, FDA administers the EPRC program to

[[Page 12150]]

protect the public health and safety. This authority provides for 
developing, amending, and administering radiation safety performance 
standards for electronic products.
    Under the FD&C Act, the EPRC applies to any electronic product that 
is defined as: (a) Any manufactured or assembled product (or component, 
part, or accessory of such product) which, when in operation, (i) 
contains or acts as part of an electronic circuit and (ii) emits (or in 
the absence of effective shielding or other controls would emit) 
electronic product radiation, or (b) any manufactured or assembled 
article which is intended for use as a component, part or accessory of 
a product described in clause (A) and which when in operation emits (or 
in the absence of effective shielding or other controls would emit) 
such radiation (see section 531(2) of the FD&C Act, 21 U.S.C. 
360hh(2)).
    Electronic product radiation is defined as: (a) Any ionizing or 
non-ionizing electromagnetic or particulate radiation or (b) any sonic, 
infrasonic, or ultrasonic wave, which is emitted from an electronic 
product as the result of the operation of an electronic circuit in such 
product (section 531(1) of the FD&C Act). Some products may fall under 
the definition of both a medical device and an electronic product (see 
section 201(h) of the FD&C Act for definition of a device and section 
531(2) of the FD&C Act for definition of electronic product). As such, 
these products may be subject to the provisions of the FD&C Act and 
FDA's regulations that apply to medical devices and electronic 
products.
    The EPRC program also directs FDA to prescribe performance 
standards for electronic products to control the emission of electronic 
product radiation. In establishing performance standards consistent 
with the statute, FDA consults with the Technical Electronic Product 
Radiation Safety Standards Committee (TEPRSSC), established under the 
Radiation Control for Health and Safety Act (RCHSA). The TEPRSSC 
functions to provide advice and consultation to FDA on the technical 
feasibility, reasonableness, and practicality of all proposed 
performance standards for electronic products (section 534(f) of the 
FD&C Act) (Ref. 8). FDA submits to TEPRSSC a proposed standard or 
amendment of a performance standard for an electronic product before 
issuing a proposed regulation in the Federal Register containing such 
standard or amendment of such standard (section 534(f)(1)(A) of the 
FD&C Act). TEPRSSC may also recommend electronic product radiation 
safety standards to FDA (section 534(f)(1)(B) of the FD&C Act).
    Upon receipt of advice from TEPRSSC, responsibility for action on 
creating or updating performance standards rests with FDA (21 CFR 
14.122(b)). Based on this advice, the creation, amendment, and 
revocation of performance standards for electronic products to control 
the emission of electronic product radiation are accomplished by 
rulemaking, including the opportunity for notice and comment (section 
534(a)-(b) of the FD&C Act).
    On October 26, 2016, a TEPRSSC meeting was held and FDA presented, 
for consultation with TEPRSSC, proposed certain amendments to the 
regulations for laser, sonic, x-ray, and other radiation emitting 
products to best align FDA's focus with the public health need and 
reduce or eliminate standards or reporting that were no longer 
considered necessary (Sec.  1040.10(a)) (Ref. 9). FDA also proposed to 
the TEPRSSC the removal of the ultrasonic therapy performance standard 
with continuing reliance on medical device review prior to marketing 
authorization. Items in these proposed amendments have been considered 
by TEPRSSC discussions as necessary.

C. Need for Amendments to the Regulations

    FDA is responsible for protecting and promoting the public health 
regarding electronic product radiation from medical devices and 
electronic products. Voluntary consensus standards regarding safety and 
essential performance have been developed and continually improved to 
increase the safety of these devices. FDA believes radiation emitting 
electronic products and devices that comply with Federal standards 
provide a reasonable assurance of safety and effectiveness when 
properly used by trained personnel, and concern has shifted to 
minimizing improper uses. FDA, patients, health workers, and industry 
recognize that medical products that emit radiation should be used only 
when medically justified to answer a clinical question or to guide 
treatment of a disease, and that the amount of radiation used should be 
limited to that necessary to accomplish the clinical task. (Refs. 3, 
10-12).
    In 2010, FDA's Center for Devices and Radiological Health (CDRH) 
launched an ``Initiative to Reduce Unnecessary Radiation Exposure from 
Medical Imaging'' (Ref. 13) to protect public health by promoting the 
appropriate use of radiation and safety features to minimize 
unnecessary radiation exposure from medical imaging. Through this 
initiative, FDA collaborates with other agencies and the health care 
professional community to mitigate factors contributing to unnecessary 
patient exposure to radiation during medical procedures. The range of 
electronic products marketed today is diverse with regards to radiation 
emission levels, product complexity, consumer use, and sales volume. 
The public risk associated with exposure to radiation from these 
products also varies significantly; however, the risks to patients can 
be mitigated by medical personnel only performing exams using radiation 
when necessary to answer a medical question, treat a disease or guide a 
procedure (Ref. 14). In accordance with FDA's directive to carry out 
the EPRC program, FDA has determined that the regulatory requirements 
can be adjusted to take account of the wide range of electronic 
products currently on the market and focus on products that pose a 
higher risk to the public.
1. Radiation Protection Recommendations
    Between 1976 and 1980, FDA issued final voluntary recommendations 
to provide industry and practitioners with recommendations for 
radiological protection for specific medical procedures (see 44 FR 
71728 at 71729). In the Federal Register of July 23, 1976 (41 FR 
30327), FDA set forth recommendations for use of specific area gonad 
shielding on patients during medical diagnostic x-ray procedures. In 
the Federal Register of December 11, 1979 (44 FR 71728), FDA issued a 
final recommendation for the voluntary establishment of quality 
assurance (QA) programs by all diagnostic facilities. FDA encouraged 
each facility to implement only those recommendations that the facility 
determined would lead to benefits in improved image quality, reduced 
radiation exposure, and/or reduced costs sufficient to compensate for 
the costs of the action. A facility can use its QA program to optimize 
radiation dose for each kind of x-ray imaging examination, procedure, 
and medical imaging task the facility performs (Refs. 3-4, 14). In the 
Federal Register of June 17, 1980 (45 FR 40976), FDA issued a final 
recommendation on administratively required dental x-ray examinations. 
FDA recommended that dental x-ray examinations only be performed after 
careful consideration of the dental or other health needs of the 
patient, based on medical judgement necessary for diagnosis, treatment, 
or prevention of disease. Dental radiography is estimated to contribute 
much less than one percent of the total

[[Page 12151]]

population's exposure to all types of radiation (medical and non-
medical) (Ref. 15).
    Since the publication of the recommendations over the last 30 
years, numerous other organizations and Federal and State agencies have 
developed more comprehensive recommendations on patient shielding, 
quality control, and the safe use of x-ray imaging in dentistry. FDA 
recognizes the significant and ongoing contributions that external 
stakeholders, such as the American Association of Physicists in 
Medicine, the American College of Radiology, the Health Physics 
Society, the Image Gently Alliance, the International Atomic Energy 
Agency, the Medical Imaging Technology Alliance, the Society of 
Interventional Radiology, the World Health Organization, and many 
others, have made to incorporate radiation protection into device 
design, practitioner training, and best practices for standards of 
care. There are communities of scientific and clinical experts, often 
with FDA collaboration, dedicated to developing radiation safety 
training programs and setting qualification and accreditation standards 
by users and facilities that are adequate to supersede FDA 
recommendations. For example, in 2003, the National Council on 
Radiation Protection and Measurements (NCRP) updated its 
recommendations on radiation protection in dentistry (Ref. 4). In 2012, 
the American Dental Association, in conjunction with FDA, updated its 
selection criteria for dental imaging with guidelines for the frequency 
of dental radiographs and radiation exposure recommendations (Ref. 5). 
In 2014, the Environmental Protection Agency's (EPA) Working Group on 
Medical Radiation, with active FDA participation, published a document 
entitled ``Federal Guidance Report No. 14. Radiation Protection 
Guidance for Diagnostic and Interventional X-Ray Procedures'' (Guidance 
Report No. 14), which provides comprehensive recommendations for 
radiation protection to medical and dental facilities (Ref. 3).
    Also, over the last decade FDA has been actively engaged with other 
State agencies to develop and publish more modern recommendations than 
those identified under FDA's regulations to promote and protect public 
health by reducing unnecessary radiation exposure from medical imaging 
(part 1000 (21 CFR part 1000)). These efforts were in response to 
increasing use of ionizing radiation for medical imaging highlighted in 
the NCRP Report No. 160 (Ref. 15). FDA strives to promote patient 
safety through the principles of radiation protection developed by the 
International Commission on Radiological Protection (ICRP) (Ref. 16). 
For example, FDA actively works with States, which have the authority 
to regulate diagnostic radiology facilities. FDA routinely provides 
input into the model State regulations (the Suggested State 
Regulations) developed by the Conference of Radiation Control Program 
Directors (CRCPD), which include suggested regulations relating to the 
use of x-ray imaging in medicine and dentistry and diagnostic imaging 
quality assurance (Ref. 17). In addition, the Centers for Medicare & 
Medicaid Services (CMS) requires advanced diagnostic imaging services 
to be accredited by a designated accrediting organization in order to 
receive Medicare reimbursement. Practitioner training and radiation 
safety are part of the accreditation requirements (Ref. 18).
    FDA has and will continue to participate actively in the 
development and maintenance of safety standards related to radiation 
protection, including IEC standards for radiography and fluoroscopy, 
computed tomography, interventional fluoroscopy, dental radiography, 
radiation therapy, laser products, and microwave ovens, among others. 
Manufacturers are required to conform with these standards in order to 
market their device in some countries, including China and Europe. Our 
participation in standards development is critical to advocating for 
industry-wide implementation of radiation protection safety features 
that result in a benefit to the public health and facilitates global 
harmonization of safety measures for radiation therapies. FDA also has 
and retains its authority over medical device premarket reviews, 
surveillance, and compliance programs--as well as the other EPRC 
reporting requirements and performance standards--to address radiation 
safety issues with respect to medical devices.
    In view of FDA's continuous collaboration with States, other 
Federal agencies, and professional organizations, FDA has determined 
that the recommendations in FDA's current regulations for radiation 
protection during medical procedures (part 1000) are obsolete and do 
not address many aspects of modern radiation control and QA as 
articulated in more contemporary guidelines and is proposing that the 
recommendations be repealed. For example, the regulations for radiation 
emitting products provide recommendations for QA programs for imaging 
using film, but almost no current facilities still use film (Sec.  
1000.55(c)(3)). FDA is proposing that it is unnecessary to revise the 
film quality control recommendations for new digital imaging equipment 
because FDA performs premarket authorization review of the digital x-
ray equipment, which includes a review of the manufacturer's device 
labeling proposed to support a reasonable assurance of safety and 
effectiveness (see 21 CFR part 892). The performance standards that 
apply to the x-ray imaging products also still apply (see Sec. Sec.  
1020.30 and 1020.31 (21 CFR 1020.30 and 1020.31)). When used as 
intended by trained practitioners, FDA believes that digital equipment 
can provide more reliable high-quality images with greater potential to 
lower radiation exposure. As discussed above, FDA believes there are 
adequate recommendations and guidelines available to provide sufficient 
guidance on the safe use of medical x-ray modalities.
    Therefore, FDA is proposing to repeal the radiation protection 
recommendations in the regulation because these recommendations have 
become outdated and there is no longer a need for FDA to specify and 
maintain a set of recommendations for practitioners. FDA encourages 
practitioners to review and apply the most current guidelines developed 
by professional societies (see the list of agencies and societies 
listed earlier in this section), along with the medical device labeling 
to ensure radiation protection. In addition to continued active 
participation in consensus standards development, FDA can also utilize 
its authority over device labeling and will continue to review device 
labeling for adequate directions for use of the product (see Sec.  
801.5 (21 CFR 801.5)). FDA will also continue its participation on 
collaborative efforts with stakeholders who are engaged in developing 
radiation safety education and standards for patient care. FDA will 
continue to amend specific FDA performance standards as appropriate to 
include aspects of radiation protection or reporting that are not 
already addressed by consensus standards.
2. Applications for Variances
    FDA may grant a variance from one or more provisions of any 
performance standard under certain conditions. Upon application of 
variances or for amendments or extensions of variances, FDA requires 
manufacturers or assemblers to submit one original and two copies of 
the application to the Agency (Sec.  1010.4(b) (21 CFR 1010.4(b))). 
When FDA receives a new application for variance, the Agency's Dockets 
Management Staff will scan the original application electronically into 
the

[[Page 12152]]

docket for a specific submission. FDA has determined that the 
requirement for multiple copies is no longer necessary because the 
docket maintains an electronic version of the application and it is an 
unnecessary regulatory burden on manufacturers to require additional 
copies. Therefore, FDA is proposing to amend the applications for 
variances section to only require a manufacturer to submit the original 
to the Dockets Management Staff.
3. Records and Reports
    The range of electronic products marketed today is diverse 
regarding radiation emission levels, product complexity, consumer use, 
and sales volume. FDA receives a large volume of records and reports 
both annually and quarterly from manufacturers of electronic products 
(Sec.  1002.1 (21 CFR 1002.1)). Industry has previously raised concerns 
about redundancy of information that FDA requires to be submitted to 
comply with both the medical device regulations and EPRC regulations 
for products that are both medical devices and electronic products. In 
the Federal Register of September 19, 1995 (60 FR 48374), FDA issued a 
final rule amending the regulations regarding requirements for 
recordkeeping and reporting of adverse events and other information 
related to radiation emitting electronic products. This rule reduced 
the recordkeeping and reporting requirements for some products, 
required only abbreviated reporting for other products, and clarified 
certain requirements.
    Based on additional experience with these products and knowledge of 
their radiation risks, FDA has concluded that the record and reporting 
requirements for these products should be tailored to focus upon 
products that have the potential to pose greater risk, while reducing 
regulatory burdens on manufacturers, dealers and distributors of 
radiation emitting electronic products that pose less risk to public 
health (Sec.  1002.1). FDA also considered what categories of EPRC 
reports were duplicative of information that would be submitted to FDA 
in a premarket review of the safety and effectiveness of a new medical 
device. For example, an initial or abbreviated product report for an 
ultrasound or x-ray system is duplicative if the firm is also expected 
to submit a premarket 510(k) notification for a new ultrasound or x-ray 
system that contains the same (or more detailed) information related to 
radiation safety features and performance. In general, current record 
and reporting requirements will remain for those products that emit the 
highest radiation levels or are sold in the largest quantities because 
they present the greatest potential risks to public health. For those 
products that present the least public health risk or for categories of 
medical-devices that FDA considers the EPRC reporting to be duplicative 
given the medical device regulations, FDA is proposing to reduce 
reporting requirements.
    In addition, FDA has identified medical and non-medical sonic 
products for which FDA believes record and reporting requirements 
should no longer be required. FDA believes the current record and 
reporting requirements for some electronic products, including 
ultrasonic therapy products, are an unnecessary burden and a source of 
confusion for these products. As a result, FDA is proposing to amend 
the record and reporting requirements to no longer require product 
reports, supplemental reports, abbreviated reports, annual reports, 
test records, or distribution records for certain products (see revised 
table 1 of Sec.  1002.1).
    FDA is proposing to remove the requirement for manufacturers to 
report model numbers of new models of a model family that do not 
involve changes in radiation emission or requirements of a performance 
standard in quarterly updates to their annual reporting (Sec.  1002.13 
(21 CFR 1002.13(c))). FDA has determined that quarterly reporting of 
new models is unnecessary. The submission of annual reports is 
sufficient to provide FDA with periodic information to regulate these 
products, and the submission of quarterly reports has been an 
unnecessary burden on industry. Generally, FDA requires specified 
product manufacturers to submit annual reports to the Agency that 
summarize certain manufacturing records (see Sec.  1002.13(a) and (b)). 
FDA is not amending these annual report requirements; however, FDA has 
determined that requiring select manufacturers to submit quarterly 
updates to FDA in addition to the annual report, is no longer necessary 
to protect the public health and safety.
    FDA believes that the revisions to the reporting and recordkeeping 
are reasonable based on the risk of certain product categories (Sec.  
1002.1). However, FDA is seeking public comments on other possible 
revisions to table 1 that may simplify the reporting requirements based 
on a reduction of unnecessary or duplicative reporting (Sec.  1002.1).
    Lastly, FDA is proposing amendments to AROs by allowing any 
manufacturer of a radiation emitting electronic product to submit 
quarterly summary reports of AROs that are not associated with a death 
or serious injury (21 CFR 803.3(w)) and not required to be reported 
under the medical device reporting regulations (Sec.  1002.20 (21 CFR 
1002.20); 21 CFR part 803). Manufacturers of electronic products are 
currently required, where reasonable grounds are suspected, to 
immediately report to FDA all AROs reported to or otherwise known to 
the manufacturer and arising from the manufacturing, testing, or use of 
any product introduced or intended for introduction into commerce by 
the manufacturer (Sec.  1002.20). FDA believes that amending the 
regulations to allow summary reporting for AROs not associated with a 
death or serious injury for electronic products extends the approach of 
eliminating or reducing duplicative reporting requirements beyond the 
medical device arena and promotes harmonization between this reporting 
and the new voluntary malfunction summary reporting program for medical 
devices (see part 803). In the Federal Register of August 17, 2018, FDA 
published the ``Voluntary Malfunction Summary Reporting Program'' 
Notice identifying the criteria and format for summary reporting in the 
quarterly reports for device malfunctions that will also be applicable 
to AROs (83 FR 40973). FDA is seeking public comments from 
manufacturers as to whether quarterly summary reports would reduce 
burden, and whether manufacturers have additional suggestions as to the 
specificity in the format, content, or timing of summary reports.
4. Diagnostic X-Ray Systems and Their Major Components
    The purpose of the performance standard for diagnostic x-ray 
systems is to protect the public health by reducing unnecessary 
exposure to ionizing radiation while assuring the clinical utility of 
the images produced. In the Federal Register of June 10, 2005 (70 FR 
33998), the FDA issued a final rule to amend the Federal performance 
standard for diagnostic x-ray systems and their major components (i.e., 
the performance standards). Under those regulations, the performance 
standard requires that assemblers who install certified components of 
diagnostic x-ray systems must assemble, install, adjust, and test the 
certified components according to the instructions of the component 
manufacturer when these certified components are installed into a 
diagnostic x-ray system (Sec.  1020.30(d)). In addition, assemblers are 
responsible for filing a report of the assembly that affirms the 
manufacturer's instructions

[[Page 12153]]

were followed in the assembly or that the certified components as 
assembled into the system meet all applicable requirements of 
Sec. Sec.  1020.30 through 1020.33 (Sec.  1020.30(d)(1)).
    Currently, all assembler reports must be on a form prescribed by 
CDRH and submitted to the Director of CDRH, to the purchaser, and, 
where applicable, to the State agency responsible for radiation 
protection within 15 days following assembly. FDA has determined that 
the reports of assembly are important for State agencies and the 
purchasers, but reporting to FDA is an unnecessary additional burden to 
the manufacturer as FDA is no longer using these reports to plan 
routine inspections of newly assembled equipment. Therefore, FDA is 
proposing to amend the regulation to remove the requirement that a 
manufacturer must submit a report of assembly of a certified component 
to the Agency. While FDA no longer needs the report to plan routine 
inspections of installed x-ray systems, other requirements in the 
performance standard for x-ray systems and their major components are 
unchanged. FDA also plans routine inspections of the x-ray equipment 
manufacturers for compliance with the quality system regulations (see 
21 CFR part 820).
    X-ray systems and certain components are still subject to FDA 
premarket review (see part 892). Compliance with FDA regulations and 
post-market surveillance allows monitoring the safety of installed 
equipment through medical device reporting (MDRs) (part 803), recalls 
(see 21 CFR part 806), notifications of defects (see 21 CFR part 1003), 
and reporting of accidental radiation occurrences (see Sec.  1002.20). 
FDA believes that, as was previously described, the history of 
continuous efforts to reduce unnecessary radiation among manufacturers 
and practitioners, consensus standards development, and other 
regulatory authorities for compliance and surveillance all support 
FDA's conclusion that reports of assembly no longer need to be 
submitted to FDA. FDA has found the information received and reviewed 
in MDRs, recalls, and other means to be sufficient for ongoing efforts 
to inform consensus standards development, guidance, or collaboration 
on improved education as a better use of resources to result in a 
broader impact to reduce unnecessary radiation exposure and protect the 
public health and safety.
5. Laser Products
    On December 18, 1989, in response to numerous questions regarding 
the applicability of regulations on laser products, and modification of 
a certified laser product, in situations in which a firm purchases a 
certified Class I laser product and incorporates it into another 
product for sale (Sec.  1040.10(i) (21 CFR 1040.10(i))), FDA issued 
``Laser Notice No. 42--Clarification of Compliance Requirements for 
Certain Manufacturers Who Incorporate Certified Class I Laser Products 
Into Their Products'' (Laser Notice No. 42) (Ref. 19). In Laser Notice 
No. 42, FDA announced its policy that it will consider firms that 
incorporate unmodified, certified Class I laser products into another 
product to be distributors of laser products certified and reported by 
other manufacturers provided certain conditions were met. If this 
proposed rule is finalized, the exception from applicability of laser 
performance standards will be expanded to include all classes of 
certified and unmodified laser products (Class I, II, IIa, IIIa, IIIb, 
and IV) that are not intended for use as a component or replacement and 
that are incorporated into another product (see proposed amendment 
Sec.  1040.10(a)(2)). These amendments, if finalized, will further 
streamline the regulation of finished certified laser products that are 
installed into another product, while providing for the same protection 
of the public health and safety from electronic product radiation from 
laser products as originally certified.
    The proposed rule does not change the requirements for distributors 
of laser products. Distributors of laser products need not submit 
initial and annual reports nor apply new certification and 
identification labels to the outside of the final product (Sec. Sec.  
1010.2 and 1010.3), which remain the responsibility of the 
manufacturer. Instead, distributors of laser products must only comply 
with the recordkeeping requirements (Sec. Sec.  1002.40 and 1002.41 (21 
CFR 1002.40 and 21 CFR 1002.41)).
    At the same time, FDA is retaining the exception from applicability 
of the laser product performance standard for uncertified laser 
products intended to be used as a component or replacement for an 
electronic product that is then certified by the manufacturer of such 
finished electronic product (see Sec.  1040.10(a)). Specifically, the 
laser product performance standards will still not apply to 
manufacturers of uncertified laser products intended to be used as a 
component or replacement in a finished electronic product that is then 
certified by the manufacturer, subject to certain conditions (see 
proposed amendment Sec.  1040.10(a)(1)(i)-(iii)). To clarify, Sec.  
1040.10(a)(1), as proposed to be amended, describing laser products 
intended for use as components and excepted from the laser performance 
standard and the associated reporting and recordkeeping requirements 
found in part 1002 remain unchanged by these amendments.
    Such exception from the laser product performance standards 
continues to not apply to removable laser systems, which must comply 
with the laser product performance standards as well as applicable 
reporting and recordkeeping requirements. Removable laser systems are 
designed to be incorporated in such a way that they may be removed 
without modification and still be capable of producing laser radiation 
when powered by a general energy source, such as those provided by wall 
transformers, batteries, or other AC or DC power (see Sec.  
1040.10(c)(2)).
    Lastly, FDA is amending the Agency's address for registration and 
listing for manufacturers of uncertified laser products that are 
intended to be used as a component and are incorporated into an 
electronic product (see proposed amendment Sec.  
1040.10(a)(1)(iii)(A)).
6. Ultrasonic Therapy Products
    Ultrasonic therapy products are both devices, under section 201(h) 
of the FD&C Act, and electronic products, under section 531(2) of the 
FD&C Act. In the Federal Register of February 17, 1978 (43 FR 7166), 
FDA issued a final rule establishing a radiation performance standard 
for ultrasonic therapy products for use in physical therapy 
manufactured on or after February 17, 1979. The standard applies to any 
device intended to generate and emit ultrasonic radiation for 
therapeutic purposes at frequencies above 16 kilohertz and to 
generators or applicators designed or specifically designed for use in 
such devices. Ultrasonic therapy devices currently must comply with the 
general performance standards for electronic products (part 1010), and 
the performance standard for ultrasonic therapy products (Sec.  1050.10 
(21 CFR 1050.10)). The performance standard for ultrasonic therapy 
products only applies to ultrasonic therapy products for use in 
physical therapy, but not the range of other therapeutic medical 
ultrasound devices. Ultrasonic therapy products, also known as 
diathermy products, are intended to generate therapeutic deep heat 
within body tissues for the treatment of selected medical conditions. 
The safety profile of medical ultrasound products is reviewed prior to 
marketing authorization to consider their intended uses by trained 
professionals who follow the manufacturer's labeling, which labeling

[[Page 12154]]

is required to provide adequate directions for use (Sec.  801.5).
    Since the time that ultrasonic therapy performance standards were 
finalized in 1979, other regulations now apply to the safety and 
effectiveness of ultrasonic therapy products. The products are subject 
to premarket authorization (see Sec.  890.5300 (21 CFR 890.5300)). 
Additionally, FDA can perform routine inspections of the device 
manufacturers for compliance with quality system regulations (see part 
820). Compliance with FDA's regulations and post-market surveillance 
also allow monitoring for the safety of equipment through medical 
device reporting (MDRs) (see part 803) and recalls (see part 806). EPRC 
notifications of defects (see part 1003) and reporting of accidental 
radiation occurrences (see Sec.  1002.20) still apply. FDA finds that 
the history of safe use, consensus standards development, and other 
regulatory authorities for compliance and surveillance are adequate to 
reduce the burden of also needing to comply with outdated performance 
standards.
    The basis for development of the ultrasonic therapy performance 
standards in 1979 is no longer relevant because FDA has since gained 
authority to sufficiently monitor the quality and safety of ultrasonic 
therapy products under the device premarket authorization review 
process. The premarket authorization review can take into consideration 
recognized IEC consensus standards and recommendations in applicable 
FDA's guidance document(s) as an alternative to conformance with the 
EPRC performance standards for the evaluation of the safety and 
effectiveness of such products (Ref. 9). The premarket review can 
determine substantial equivalence of the device performance and 
labeling to a predicate product or premarket approval to demonstrate a 
reasonable assurance of safety and effectiveness and adequate 
directions for use (see Sec.  801.5).
    As a result, FDA is proposing to repeal the ultrasonic therapy 
products performance standards because industry may conform to the 
recognized IEC standards for these products, which provides at least 
the same level of protection of the public health and safety from 
electronic radiation as FDA performance standards, and provides greater 
flexibility for changes in technology for ultrasonic therapy products. 
The Agency has recommended through guidance that industry should 
conform with IEC standards 60601-2-5 and 61689 to address the 
performance standards for ultrasonic therapy (part 1050). Most of 
industry already comply with these FDA recognized consensus standards. 
FDA has published an ultrasonic diathermy device guidance entitled, 
``Policy Clarification and Premarket Notification [510(k)] Submissions 
for Ultrasonic Diathermy Devices; Guidance for Industry and Food and 
Drug Administration Staff'' (Ref. 20). The guidance outlines a policy 
that, if firms provide a declaration of conformity with the relevant 
provisions of the current FDA recognized versions of the IEC 60601-2-5 
and IEC 61689 standards, FDA does not intend to consider whether firms 
comply with certain regulatory requirements (see Sec.  1050.10).
    FDA believes that the foregoing regulatory controls, such as 
medical device premarket review, as well as quality controls, 
surveillance, and recall authorities are adequate to monitor and 
address safety issues that arise from any reports of adverse events 
with these products. As a result, FDA is proposing to repeal the 
performance standards for ultrasonic therapy products because these 
standards apply to a limited subset of devices used in physical therapy 
(see Sec.  890.5300) for which safety issues devices have been and will 
continue to be handled through premarket regulatory review processes as 
well as under other medical device regulatory authorities, such as MDRs 
and device recalls.

IV. Legal Authority

    FDA is issuing this proposed rule under the same authority under 
which FDA initially issued these regulations, the device and general 
administrative provisions of the FD&C Act (21 U.S.C. 321, 351, 352, 
360, 360e-360j, 360hh-360ss, 371, 374, and 381). FDA has the authority 
under section 534 of the FD&C Act to amend the performance standard for 
diagnostic x-ray systems and their major components, amend the 
performance standard for laser products, and repeal radiation 
protection recommendations and the performance standard for ultrasonic 
therapy products, as provided for in this proposed rule.

V. Description of the Proposed Rule

A. Scope

    We are proposing to amend and repeal the parts of the radiological 
health regulations covering recommendations for radiation protection 
(part 1000), certain reporting and records of electronic products 
(parts 1002, 1010, and 1020), and performance standards of laser 
products (part 1040) and ultrasonic therapy devices (part 1050). These 
proposed changes to the regulations are intended to reduce regulatory 
requirements that are outdated and otherwise clarify requirements for 
protecting the public health against exposure to specific radiation 
emitting electronic products and medical devices. This action is part 
of FDA's implementation of EOs 13771 and 13777.

B. Proposed Repeal of Radiation Protection Recommendations

    As stated above in section III, FDA believes there are adequate 
recommendations from FDA, interagency work groups, and professional 
organizations as well as State and accreditation/certification 
requirements on practitioners and facilities to mitigate patients' and 
health professionals' exposure to radiation from medical imaging. The 
recommendations found in FDA's current regulations are now outdated and 
can be removed without impacting public health, and practitioners and 
industry can rely on more recent and comprehensive recommendations. FDA 
is proposing to repeal the following regulations for radiation 
protection recommendations: (1) Recommendation for the use of specific 
area gonad shielding on patients during medical diagnostic x-ray 
procedures (Sec.  1000.50), (2) recommendation for QA programs in 
diagnostic radiology facilities (Sec.  1000.55), and (3) recommendation 
on administratively required dental x-ray examinations (Sec.  1000.60). 
Also, FDA is proposing to repeal the definition of phototherapy 
products because it is no longer necessary with the removal of certain 
reporting requirements identified in records and reports for radiation 
emitting electronic products (Sec.  1000.3(s); see table 1 of Sec.  
1002.1).

C. Proposed Amendment About Applications for Variances

    FDA has determined that it is unnecessary for manufacturers 
submitting an application for variance to submit two copies of the 
application in addition to the original (Sec.  1010.4(b)). Upon receipt 
of a new application for variance by mail, FDA's Dockets Management 
Staff will scan the original application electronically into the docket 
for a specific submission; therefore, FDA is proposing to amend this 
regulation by removing the requirement for manufacturers to submit two 
additional copies of the application to Dockets Management Staff. 
Applications for variance can also be submitted electronically through 
the Regulations.gov website to Docket No. FDA-2013-S-0610 (https://
www.regulations.gov/docket?D=FDA-

[[Page 12155]]

2013-S-0610) as a new comment with an upload of the variance 
application materials.

D. Proposed Amendments About Records and Reports

    FDA has reviewed the regulations and is proposing that certain 
electronic product recordkeeping and reporting requirements are 
unnecessary for protecting the public health and safety, and therefore 
is proposing to simplify the applicability of the recordkeeping and 
reporting requirements (part 1002). In addition, FDA is proposing to 
change the frequency of some reports and recordkeeping, such as 
quarterly reporting, because they are unnecessary requirements.
1. Table 1 Revision to Applicability
    FDA is proposing to amend the list of records and reports in table 
1 to revise the applicability of the recordkeeping and reporting 
requirements for some products (Sec.  1002.1). FDA recognizes that, for 
some products, meeting the preexisting recordkeeping and reporting 
requirements are not necessary for protection of the public health and 
safety. The revisions will eliminate some requirements, clarify others, 
and combine some reporting requirements identified in the table. For 
instance, receiving reports for x-ray systems and ultrasonic systems is 
redundant to the medical device premarket review, which provides FDA 
more information on safety and effectiveness of an electronic product 
and medical device. These proposed amendments, if finalized, will 
improve protection of the public health and safety while reducing 
regulatory burdens on manufacturers, dealers, and distributors of 
radiation emitting electronic products. The amendments will remove 
reports that FDA no longer considers necessary low-risk products, which 
will allow better utilization of resources on high-priority aspects of 
radiation safety for products with greater risk. Therefore, FDA 
proposes to reduce recordkeeping and reporting requirements for some 
products and clarify the applicability of certain requirements for 
other products. The proposed revisions to table 1 are:
    a. Remove the following products from all of the record and 
reporting requirements under part 1002: (a) Television products (Sec.  
1020.10) with <25 kilovolt (kV) and >=25kV and <0.1 milliroentgens per 
hour (mR/hr) isoexposure rate limit curve (IRLC), (b) phototherapy 
products, and (c) acoustic products including ultrasonic therapy (Sec.  
1050.10), diagnostic ultrasound, medical ultrasound other than therapy 
or diagnostic, and nonmedical ultrasound. However, these proposed 
amendments do not remove the general notification of defect 
requirements for all electronic products (21 CFR part 1003) by 
manufacturers. FDA believes removing the records and reporting 
requirements for these types of low risk products will not undermine 
the protection of the public health and safety. The medical device 
reporting requirements (21 CFR part 803) and premarket notification 
requirements (21 CFR part 807, subpart E) still apply to phototherapy 
products and ultrasonic medical products. In the event there is an 
issue with the product, FDA's general notification of defect 
requirements and medical device regulations are sufficient for 
providing FDA with necessary information.
    b. Remove the following products from the requirements for product 
reports, supplemental reports and annual reports: (a) Computed 
tomography, (b) x-ray systems, (c) tube housing assembly, (d) x-ray 
control, (e) x-ray high voltage generator, (f) beam-limiting devices, 
(g) spot-film devices and image intensifies manufactured after April 
26, 1977, and (h) T lamps. However, these proposed amendments do not 
remove the general notification of defect requirements for all 
electronic products (21 CFR part 1003) by manufacturers. These devices 
continue to be regulated under the medical device regulations, 
including reporting requirements (21 CFR part 803) and premarket 
notification requirements (21 CFR part 807, subpart E) for computed 
tomography and x-ray systems. The reporting for T lamps is being made 
consistent with R lamps as FDA believes the abbreviated reporting for R 
and T lamps is sufficient for protection of the public health and 
safety.
    c. Remove the following products from the requirements for 
abbreviated reports: (a) X-ray table or cradle, (b) x-ray film charger, 
(c) vertical cassette holders mounted in a fixed location and cassette 
holders with front panels, (d) cephalometric devices manufactured after 
February 25, 1978, and (e) image receptor support devices for 
mammographic x-ray systems manufactured after September 5, 1978. 
However, these proposed amendments do not remove the general 
notification of defect requirements for all electronic products (21 CFR 
part 1003) by manufacturers. These devices continue to be regulated 
under the medical device regulations, including reporting requirements 
(21 CFR part 803) and premarket notification requirements (21 CFR part 
807, subpart E) for diagnostic x-ray systems and products. FDA believes 
that submission of test records and distribution records and continued 
regulation as medical devices is sufficient for protection of the 
public health and safety.
    d. Remove the following products from the requirements for 
abbreviated reports and annual reports: PRODUCTS INTENDED TO PRODUCE 
PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET 
DIAGNOSTIC X-RAY (Medical). This reporting category is intended to 
cover other medical devices that emit radiation, such as linear 
accelerators. However, because there are no EPRC performance standards 
for this category, these reporting requirements were primarily 
informational only. FDA believes this reporting is unnecessary given 
other FDA regulations to review and classify medical devices, including 
premarket review to evaluate safety and effectiveness.
    e. Remove the following products from the requirements for 
supplemental reports: (a) Television with >=0.1mR/hr IRLC 5, (b) 
microwave ovens (Sec.  1030.10), and (c) class IIa, II, IIIa lasers and 
products other than class I products containing such lasers. 
Manufacturers of these products will continue to submit product reports 
and annual reports, which FDA believes is sufficient for protection of 
the public health and safety. FDA believes supplemental reporting is 
unnecessary given the information reviewed in the product reports and 
the relatively lower-risk of these products.
    f. Remove the T lamps products from the requirements for product 
reports, supplemental reports, and annual reports and transfer the 
product to the same category as R lamps. Manufacturers of T lamps 
products will now instead be required to submit abbreviated reports, 
which FDA believes promotes consistency for the two types of lamps and 
provides sufficient oversight for protection of the public health and 
safety.
    g. Remove ``diagnostic'' from ``Cabinet Diagnostic X-ray'' to match 
the name of the standard ``Cabinet X-Ray.''
    The following proposed changes to table 1 of Sec.  1002.1 include 
deletions that are indicated in a bold font and by a strikethrough and 
replacements shown in bold font:
BILLING CODE 4164-01-P

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[GRAPHIC] [TIFF OMITTED] TP01AP19.002


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[GRAPHIC] [TIFF OMITTED] TP01AP19.003


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[GRAPHIC] [TIFF OMITTED] TP01AP19.004

BILLING CODE 4164-01-C

[[Page 12159]]

    FDA is seeking public comments on other revisions to table 1 that 
may simplify the table and reduce unnecessary or duplicative reporting 
(Sec.  1002.1).
    2. Eliminating citation reserved.
    FDA is proposing to eliminate the citation reserve under Sec.  
1002.2 because it is no longer necessary.
    3. Eliminating quarterly updates to the annual reports.
    FDA is proposing to eliminate the requirement for manufacturers to 
report model numbers of new models of a model family that do not 
involve changes in radiation emission or requirements of a performance 
standard in quarterly updates to their annual reporting (Sec.  
1002.13(c)). Generally, other subsections require specified product 
manufacturers to submit annual reports to FDA which summarize certain 
manufacturing records (Sec.  1002.13(a) and (b)). FDA is not amending 
these annual reporting requirements.
    4. Reporting of AROs.
    FDA is proposing to amend the timing for submission of reporting 
requirements for AROs that are not associated with a death or serious 
injury (Sec.  1002.20). The proposed amendment will allow manufacturers 
of a radiation emitting electronic product to submit quarterly summary 
reports of AROs that are not associated with a death or serious injury 
and not required to be reported under the medical device reporting 
regulations (Sec.  1002.20; part 803). FDA believes that amending the 
regulations to allow summary reporting for AROs for electronic products 
extends the approach of eliminating or reducing duplicative reporting 
beyond the medical device arena and promotes harmonization between this 
reporting and the new voluntary malfunction summary reporting program 
for medical devices (part 803; 83 FR 40973).

E. Proposed Amendment About Diagnostic X-ray Systems and Their Major 
Components

    FDA is proposing to amend the reports of assembly requirements for 
major components of diagnostic x-ray systems to no longer require 
assemblers who install certified components to submit a report of 
assembly, Form FDA 2579, to CDRH (Ref. 21) (Sec.  1020.30(d)). FDA will 
withdraw the language to require submission to ``the Director'' in this 
subsection, but will still publish a PDF form online for assemblers to 
download, complete, and provide to applicable States and purchasers as 
required.

F. Proposed Amendments About Laser Products

    FDA is proposing to amend the laser product regulations to clarify 
and add exceptions to the applicability of the laser product 
performance standards (see Sec. Sec.  1040.10 and 1040.11) to: (1) 
Uncertified laser products that are intended to be used as a component 
and are incorporated into an electronic product that is then certified 
by the manufacturer of a finished electronic product and (2) a 
manufacturer who incorporates an unmodified laser product into another 
product when such laser product is not intended for use as a component 
or replacement and such laser product is certified by the manufacturer 
of such laser product, subject to certain conditions (Sec.  
1040.10(a)). In addition, FDA is amending the Agency's address for 
registration and listing for manufacturers of uncertified laser 
products that are intended to be used as a component and are 
incorporated into an electronic product (Sec.  1040.10(a)(1)). The new 
address that manufacturers are required to submit their registration 
and listing is the Director, Division of Radiological Health, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993-
0002. Alternatively, reports may be submitted electronically through 
FDA's eSubmitter (Ref. 22).

G. Proposed Repeal of Ultrasonic Therapy Products Performance Standard

    FDA is proposing to repeal the performance standard for ultrasonic 
therapy products (Sec.  1050.10). The standard can be repealed because 
it is limited to a subset of physical therapy devices with an outdated 
standard in FDA's current regulations (see Sec.  890.5300), but for 
which safety issues for these devices have been and will continue to be 
handled through medical device premarket regulatory processes, as well 
as under other medical device regulatory authorities, such as MDRs and 
device recalls.

VI. Proposed Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after the date of publication of the 
final rule in the Federal Register.

VII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under E.O. 12866, 
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). EOs 
12866 and 13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). E.O. 13771 requires that 
the costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations'' (Ref. 1). We believe 
that this proposed rule is not a significant regulatory action as 
defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. This proposed rule will reduce regulations that are outdated 
and otherwise clarify existing requirements. Because the proposed rule 
does not impose any additional regulatory burdens, we certify that the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $150 
million, using the most current (2017) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    Benefits are estimated in terms of cost savings. Industry cost 
savings are derived by estimating the savings in reduced labor 
resulting from the reduction in reporting, recordkeeping, and third-
party disclosure requirements. Cost savings to FDA result from the 
reduction in labor hours required to review reports. The total present 
value cost savings over a 20-year time period are $62.8 million at a 7 
percent discount rate and $88.2 million at a 3 percent discount rate. 
Annualized total cost savings are $5.93 million. We estimate the costs 
to read the rule for all reporting respondents. The present

[[Page 12160]]

value costs are $1.47 million and the annualized costs calculated over 
a 20-year time period are $0.14 million at a 7 percent discount rate 
and $0.10 million at a 3 percent discount rate.

                                     Table 2--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                   Period
                Category                     Primary    Low estimate      High      Year dollars    Discount       covered               Notes
                                            estimate                    estimate                    rate (%)       (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.         $5.93         $5.93         $5.93          2016             7            20  ..........................
                                                 $5.93         $5.93         $5.93          2016             3            20
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Annualized Quantified...............  ............  ............  ............  ............             7  ............  None.
                                                                                                             3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Qualitative.........................  ............  ............  ............  ............  ............         None.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.         $0.14         $0.14         $0.14          2016             7            20  ..........................
                                                 $0.10         $0.10         $0.10          2016             3            20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Quantified...................  ............  ............  ............  ............             7  ............  ..........................
                                                                                                             3
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized          ............  ............  ............  ............             7  ............  None.
     $millions/year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          ............  ............  ............             3  ............  ............  ..........................
From/To.................................                    From:
                                                                    To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/     ............  ............  ............  ............             7  ............  None.
 year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                          ............  ............  ............             3  ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To.................................                    From:
                                                                    To:
Effects:
--------------------------------------------------------------------------------------------------------------------------------------------------------
    State, Local, or Tribal Government:   ............
     No estimated effect..
    Small Business: No estimated effect.  ............
Wages: No estimated effect..............  ............
Growth: No estimated effect.............  ............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with E.O. 13771, in table 3 we estimate present and 
annualized values of costs and cost savings over an infinite time 
horizon. Based on these cost savings, this proposed rule would be 
considered a deregulatory action under E.O. 13771.

                                                             Table 3--EO 13771 Summary Table
                                               [In $ millions 2016 dollars, over a perpetual time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $1.47           $1.47           $1.47           $1.47           $1.47           $1.47
Present Value of Cost Savings...........................           84.65           84.65           84.65          197.52          197.52          197.52
Present Value of Net Costs..............................          -83.18          -83.18          -83.18         -196.05         -196.05         -196.05
Annualized Costs........................................            0.10            0.10            0.10            0.04            0.04            0.04
Annualized Cost Savings.................................            5.93            5.93            5.93            5.93            5.93            5.93
Annualized Net Costs....................................           -5.82           -5.82           -5.82           -5.88           -5.88           -5.88
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    FDA has examined the economic implications of the proposed rule as 
required by the Regulatory Flexibility Act. If a rule will have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act requires agencies to analyze regulatory 
options that would lessen the economic effect of the rule on small 
entities. Because the proposed rule does not impose any additional 
regulatory burdens, we certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 23) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and (i) and 25.34(c) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
an environmental assessment nor an

[[Page 12161]]

environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in parts 1002 through 1050 have been 
approved under OMB control number 0910-0025, Electronic Products. The 
amendments in this proposed rule, if finalized, necessitate revisions 
to OMB control number 0910-0025. A description of revisions to the 
annual reporting, recordkeeping, and third-party disclosure burden 
estimates is given in the PRA, Description section of this document. 
Included in the estimate is the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing each collection of information.
    Tables 4, 5, and 6 describe revisions to the burden estimates, as 
well as the other information collections currently approved under OMB 
control number 0910-0025. For the convenience of the reader, we have 
noted for each information collection whether we are requesting 
revision.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Electronic Products.
    Description: FDA is proposing to amend its regulations for 
requirements for certain reporting and records of electronic products 
by removing specific reporting, as well as repealing outdated 
recommendations for radiation protection and performance standards, and 
removing submission requirements for copies of certain applications and 
forms to alleviate regulatory burden to both FDA and industry.
    The records and reporting requirements for electronic products and 
medical devices include annual reports and test records depending upon 
the specific type of electronic product. FDA has determined upon review 
of the records and reporting requirements that some of the requirements 
are unnecessary or may be duplicative of other reporting requirements 
by FDA and State regulators.
    Description of Respondents: The respondents to this information 
collection are electronic product manufacturers, importers, and 
assemblers of electronic products from private sector, for-profit 
businesses.

                                                      Table 4--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
         Activity; 21 CFR section                     FDA form               Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response         \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product reports--1002.10(a)-(k) \3\.......  3639--Cabinet x-ray.........           1,149             2.2           2,529              24          60,685
                                            3632--Laser.................
                                            3640--Laser light show......
                                            3630--Sunlamp...............
                                            3659--TV....................
                                            3660--Microwave oven........
                                            3801--UV lamps..............
Product safety or testing changes--         ............................             440             2.5           1,100             0.5             550
 1002.11(a)-(b) \3\.                                                                                                        (30 minutes)
Abbreviated reports--1002.12 \3\..........  3629--General abbreviated                 54             1.8              97               5             485
                                             report.
                                            3663--Microwave products
                                             (non-oven).
Annual reports--1002.13(a)-(b) \3\........  3628--General...............           1,410             1.3           1,833              18          32,994
                                            3634--TV....................
                                            3641--Cabinet x-ray.........
                                            3643--Microwave oven........
                                            3636--Laser.................
                                            3631--Sunlamp...............
Accidental radiation occurrence reports--   3649--ARO...................              75               4             300               2             600
 1002.20 \3\.
Exemption requests--1002.50(a) and 1002.51  3642--General correspondence               4             1.3               5               1               5
 \4\.
Product and sample information--1005.10     2767--Sample product........               5               1               5             0.1               1
 \4\.                                                                                                                        (6 minutes)
Identification information and compliance   2877--Imports declaration...          12,620             2.5          31,550             0.2           6,310
 status--1005.25 \4\.                                                                                                       (12 minutes)
Alternate means of certification--          ............................               1               2               2               5              10
 1010.2(d) \4\.
Variance--1010.4(b) \4\...................  3633--General variance                   350             1.1             385             1.2             462
                                             request.
                                            3147--Laser show variance
                                             request.
                                            3635--Laser show
                                             notification.

[[Page 12162]]

 
Exemption from performance standards--      ............................               1               1               1              22              22
 1010.5(c) and (d) \4\.
Alternate test procedures--1010.13 \4\....  ............................               1               1               1              10              10
Microwave oven exemption from warning       ............................               1               1               1               1               1
 labels--1030.10(c)(6)(iv) \4\.
Laser products registration--               3637--Original equipment                  70             2.9             203               3             609
 1040.10(a)(3)(i) \4\.                       manufacturer (OEM) report.
                                                                         -------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............         102,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.
\3\ We request revision of this information collection.
\4\ The burden estimate for this information collection is currently approved and included for the convenience of the reader. We do not request revision
  of this line item at this time.


                                Table 5--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
    Activity; 21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping        \2\
----------------------------------------------------------------------------------------------------------------
Manufacturers records--1002.30             1,409           1,650       2,324,850            0.12         278,982
 and 1002.31(a) \3\.............                                                     (7 minutes)
Dealer/distributor records--               2,909              50         145,450            0.05           7,273
 1002.40 and 1002.41 \3\........                                                     (3 minutes)
Information on diagnostic x-ray               50               1              50             0.5              25
 systems--1020.30(g) \4\........                                                    (30 minutes)
Laser products distribution                   70               1              70               1              70
 records--1040.10(a)(3)(ii) \4\.
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         286,350
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours have been rounded.
\3\ We request revision of this information collection.
\4\ The burden estimate for this information collection is currently approved and included for the convenience
  of the reader. We do not request revision of this line item at this time.


                            Table 6--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR Section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure        \2\
----------------------------------------------------------------------------------------------------------------
Technical and safety information               1               1               1              12              12
 for users--1002.3 \3\..........
Dealer/distributor records--                  30               3              90               1              90
 1002.40 and 1002.41 \3\........
Television receiver critical                   1               1               1               1               1
 component warning--
 1020.10(c)(4) \3\..............
Cold cathode tubes--                           1               1               1               1               1
 1020.20(c)(4) \3\..............
Report of assembly of diagnostic           1,230              34          41,820             0.3          12,546
 x-ray components--1020.30(d),                                                      (18 minutes)
 (d)(1)-(2) (Form FDA 2579--
 Assembler report) \4\..........
Information on diagnostic x-ray                6               1               6              55             330
 systems--1020.30(g) \3\........
Statement of maximum line                      6               1               6              10              60
 current of x-ray systems--
 1020.30(g)(2) \3\..............
Diagnostic x-ray system safety                 6               1               6             200           1,200
 and technical information--
 1020.30(h)(1)-(4) \3\..........
Fluoroscopic x-ray system safety               5               1               5              25             125
 and technical information--
 1020.30(h)(5)-(6) and
 1020.32(a)(1), (g), and (j)(4)
 \3\............................
CT equipment--1020.33(c)-(d),                  5               1               5             150             750
 (g)(4), and (j) \3\............
Cabinet x-ray systems                          6               1               6              40             240
 information--1020.40(c)(9)(i)-(
 ii) \3\........................
Microwave oven radiation safety                1               1               1              20              20
 instructions--1030.10(c)(4) \3\
Microwave oven safety                          1               1               1              20              20
 information and instructions--
 1030.10(c)(5)(i)-(iv) \3\......

[[Page 12163]]

 
Microwave oven warning labels--                1               1               1               1               1
 1030.10(c)(6)(iii) \3\.........
Laser products information--                   2               1               2              20              40
 1040.10(h)(1)(i)-(vi) \4\......
Laser product service                          2               1               2              20              40
 information--1040.10(h)(2)(i)-(
 ii) \4\........................
Medical laser product                          2               1               2              10              20
 instructions--1040.11(a)(2) \3\
Sunlamp products instructions--                1               1               1              10              10
 1040.20 \3\....................
Mercury vapor lamp labeling--                  1               1               1               1               1
 1040.30(c)(1)(ii) \3\..........
Mercury vapor lamp permanently                 1               1               1               1               1
 affixed labels--1040.30(c)(2)
 \3\............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,508
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Total hours have been rounded.
\3\ The burden estimate for this information collection is currently approved and included for the convenience
  of the reader. We do not request revision of this line item at this time.
\4\ We request revision of this information collection.

    The proposed revised estimates were generated from discussions with 
subject matter experts at FDA.
    FDA is proposing to revise the applicability of the recordkeeping 
and reporting requirements for some products (Sec.  1002.1). We revised 
the burden estimates for product reports, abbreviated reports, and 
annual reports by reducing the number of respondents to reflect the 
revised applicability of the recordkeeping and reporting requirements. 
We also proposed to revised Form FDA 3646 ``Mercury Vapor Lamp Products 
Radiation Safety Report'' (now listed under Abbreviated Reports 
consistent with the revision of Sec.  1002.1) and removed the following 
forms:
     Form FDA 3626, ``A Guide for the Submission of Initial 
Reports on Diagnostic X-Ray Systems and Their Major Components''
     Form FDA 3627, ``Diagnostic X-Ray CT Products Radiation 
Safety Report''
     Form FDA 3638, ``Guide for Filing Annual Reports for X-Ray 
Components and Systems,''
     Form FDA 3644, ``Guide for Preparing Product Reports for 
Ultrasonic Therapy Products''
     Form FDA 3645, ``Guidance for Preparing Annual Reports for 
Ultrasonic Therapy Products,''
     Form FDA 3647, ``Guide for Preparing Annual Reports on 
Radiation Safety Testing of Mercury Vapor Lamps''
     Form FDA 3661, ``Guide for the Submission of an 
Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette 
Holders Intended for Diagnostic Use''
     Form FDA 3662, ``Guide for Submission of an Abbreviated 
Radiation Safety Reports on Cephalometric Devices Intended for 
Diagnostic Use''
    The proposed revised applicability of the recordkeeping and 
reporting requirements for dealer/distributor records (see Sec. Sec.  
1002.40 and 1002.41) may result in a small decrease in the number of 
respondents. However, upon calculating and rounding the estimated 
annual number of respondents, we have determined there is no change to 
the current burden estimate for this information collection.
    FDA is eliminating requirements for manufacturers to report model 
numbers of new models of a model family that do not involve changes in 
radiation emission or requirements of a performance standard in 
quarterly updates to their annual reporting (Sec.  1002.13(c)). We have 
removed the burden estimate associated with Sec.  1002.13(c). 
Generally, other subsections require specified product manufacturers to 
submit annual reports to FDA which summarize certain manufacturing 
records (Sec.  1002.13(a) and (b)). FDA is not amending these annual 
report requirements.
    FDA is proposing to amend the timing for submission of reporting 
requirements for AROs that are not associated with a death or serious 
injury (Sec.  1002.20). The proposed amendment will allow manufacturers 
of a radiation emitting electronic product to submit quarterly summary 
reports of AROs that are not associated with a death or serious injury 
and not required to be reported under the medical device reporting 
regulations (Sec.  1002.20; part 803). FDA believes that amending the 
regulations to allow summary reporting for AROs for electronic products 
extends the approach of eliminating or reducing duplicative reporting 
requirements beyond the medical device arena and promotes harmonization 
between this reporting and the new voluntary malfunction summary 
reporting for medical devices (see part 803; ``Medical Devices and 
Device-Led Combination Products; Voluntary Malfunction Summary 
Reporting Program for Manufacturers'' (83 FR 40973, August 17, 2018)).
    FDA is also proposing to amend the applications for variances 
process (Sec.  1010.4(b)) to no longer require a manufacturer to submit 
two additional copies with the original documents. While this amendment 
would not generate any substantive change to the information 
collection, respondents may realize a small monetary savings from the 
usual and customary administrative expenses associated with the 
preparation of the copies.
    FDA is proposing to amend the reports of assembly requirements for 
major components of diagnostic x-ray systems to no longer require 
assemblers who install certified components to submit a report of 
assemblies, Form FDA 2579, to CDRH (Sec.  1020.30(d)(1)) (Ref. 22). FDA 
also proposes to withdraw the language to require submission to ``the 
Director'' in this subsection, but will still publish a PDF form online 
for assemblers to download, complete, and provide to applicable States 
and purchasers as required. We have moved the corresponding information 
collection burden estimate from reporting to third-party disclosure 
burden and revised Form FDA 2579.
    FDA is proposing to amend the laser products regulation to add an 
exception to the applicability of the laser product performance 
standards (see Sec. Sec.  1040.10 and 1040.11) to a manufacturer who 
incorporates an unmodified laser product into another product when such 
laser product is not intended for use as a component or replacement and 
such laser product is certified by the

[[Page 12164]]

manufacturer of such laser product, subject to certain conditions 
(Sec.  1040.10(a)). We have reduced the number of respondents in our 
burden estimate to reflect the amendment.
    FDA is proposing to repeal the performance standards for ultrasonic 
therapy products (Sec.  1050.10). We have removed the burden estimate 
associated with Sec.  1050.10.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title of the information collection.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. These revisions will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval 
of these revisions in the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. We have determined that this 
proposed rule does not contain policies that have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.
    We note that the current performance standards at Sec.  1040.10 
issued under section 534 of the FD&C Act preempt the States from 
establishing or continuing in effect any standard that is not identical 
to the Federal standard pursuant to section 542 of the FD&C Act (21 
U.S.C. 360ss). Those standards were issued before the E.O. We believe 
this preemption is consistent with section 4(a) of the E.O. which 
requires agencies to ``construe . . . a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
at section 542 of the FD&C Act that preempts the States from 
establishing, or continuing in effect, any standard with respect to an 
electronic product which is applicable to the same aspect of product 
performance as a Federal standard prescribed pursuant to section 534 of 
the FD&C Act and which is not identical to the Federal standard. (See 
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, 
Inc., 552 U.S. 312 (2008)). Section 542 of the FD&C Act does allow 
States to impose a more restrictive standard regarding emissions of 
radiation from electronic products under certain circumstances.
    This proposed rule does not impose any new performance standard 
requirements. This proposed rule prescribes more defined exceptions 
from the applicability of Federal standards (under proposed amendments 
to Sec.  1040.10(a)) and a reduction in Federal standards (through 
repeal of Sec.  1050.10) pursuant to section 534 of the FD&C Act. To 
the extent that the proposed rule, if finalized, removes or excludes 
applicability of certain Federal standards, any State issued 
performance standards are no longer preempted.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have tentatively determined that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian tribes, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes. 
The Agency solicits comments from tribal officials on any potential 
impact on Indian Tribes from this proposed action.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. They also can be purchased as a pdf or as 
hard copy (or both together, at a discounted price) from NCRP 
(www.ncrponline.org). FDA has verified the website addresses, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.

*1. E.O. 13771 (January 30, 2017), available at https://www.federalregister.gov/documents/2017/02/03/2017-02451/reducing-regulation-and-controlling-regulatory-costs.
*2. E.O. 13777 (February 24, 2017), available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.
*3. EPA, Interagency Working Group on Medical Radiation, Federal 
Guidance Report No. 14. ``Radiation Protection Guidance for 
Diagnostic and Interventional X-Ray Procedures,'' 2014, available at 
https://www.epa.gov/sites/production/files/2015-05/documents/fgr14-2014.pdf.
4. NCRP, ``Radiation Protection in Dentistry,'' Report No. 145, 
2003, available at https://ncrponline.org/publications/reports/ncrp-reports-145/.
*5. American Dental Association and FDA, ``Dental Radiographic 
Examinations: Recommendations for Patient Selection and Limiting 
Radiation Exposure,'' Revised: 2012, available at http://
www.ada.org/~/media/ADA/Member%20Center/FIles/
Dental_Radiographic_Examinations_2012.pdf.
*6. CRCPD, ``Part F-Medical Diagnostic and Interventional X-ray 
Imaging and Systems,'' available at https://c.ymcdn.com/sites/www.crcpd.org/resource/resmgr/docs/SSRCRs/F_Part_2015.pdf.
*7. The American College of Radiology publishes and regularly 
updates Practice Parameters, Technical Standards, and 
Appropriateness Criteria[supreg], available at https://www.acr.org/Quality-Safety/Appropriateness-Criteria.
*8. Department of Health and Human Services, FDA, Charter for 
Technical Electronic Product Radiation Safety Standards Committee, 
available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/UCM537440.pdf.
*9. 2016 TEPRSSC Meeting, October 25-26, 2016, available at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/ucm526004.htm.
10. NCRP, Radiation Dose Management for Fluoroscopically-Guided 
Interventional Procedures, Report No.168, 2010, available at https://ncrponline.org/publications/reports/ncrp-report-168/.
*11. ICRP, ``Radiological Protection in Medicine.'' Publication 105. 
Ann ICRP. 2007;37(6): 1-63, available at http://www.icrp.org/publication.asp?id=ICRP%20Publication%20105.
12. NCRP, Reference levels and achievable doses in medical and 
dental imaging: recommendations for the United States, Report No. 
172, 2012, available at

[[Page 12165]]

https://ncrponline.org/publications/reports/ncrp-report-172/.
*13. FDA, CDRH Health, Initiative to Reduce Unnecessary Radiation 
Exposure from Medical Imaging (2010), available at https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm.
*14. FDA, Medical X-ray Imaging, available at https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/default.htm.
*15. NCRP, ``Ionizing Radiation Exposure of the Population of the 
United States,'' Report No. 160, 2009, available at https://ncrponline.org/publications/reports/ncrp-report-160-2/.
*16. ICRP, ``The 2007 Recommendations of the International 
Commission on Radiological Protection. ICRP publication 103.'' Ann 
ICRP. 2007;37(2-4): 1-332, available at http://www.icrp.org/publication.asp?id=ICRP%20Publication%20103.
*17. CRCPD, Suggested State Regulations for Control of Radiation, 
available at https://www.crcpd.org/page/ssrcrs.
*18. Centers for Medicare & Medicaid Services, Accreditation of 
Advanced Diagnostic Imaging Suppliers, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Accreditation-of-Advanced-Diagnostic-Imaging-Suppliers.html.
*19. FDA, ``Laser Notice No. 42--Clarification of Compliance 
Requirements for Certain Manufacturers Who Incorporate Certified 
Class I Laser Products Into Their Products,'' December 18, 1989, 
available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095307.pdf.
*20. FDA, ``Policy Clarification and Premarket Notification [510(k)] 
Submissions for Ultrasonic Diathermy Devices; Final Guidance for 
Industry and Food and Drug Administration Staff,'' available at 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM573663.pdf.
*21. FDA, Report of Assembly of Diagnostic X-ray System, Form FDA 
2579, available at https://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107879.htm.
*22. FDA eSubmitter, available at https://www.fda.gov/forindustry/fdaesubmitter/default.htm.
*23. Preliminary Economic Analysis of Impacts: Radiological Health 
Regulations; Amendments to Records and Reports for Radiation 
Emitting Electronic Products; Amendments to Performance Standards 
for Diagnostic X-ray, Laser and Ultrasonic Products, available at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 1000

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements, X-rays.

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements, X-rays.

21 CFR Part 1010

    Administrative practice and procedure, Electronic products, 
Exports, Radiation protection.

21 CFR Part 1020

    Electronic products, Medical devices, Radiation protection, 
Reporting and recordkeeping requirements, Television, X-rays.

21 CFR Part 1040

    Electronic products, Labeling, Lasers, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements.

21 CFR Part 1050

    Electronic products, Medical devices, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR parts 1000, 1002, 1010, 1020, 1040, and 1050 be amended as 
follows:

PART 1000--GENERAL

0
1. The authority citation for part 1000 continues to read as follows:

    Authority:  21 U.S.C. 360hh-360ss.


Sec.  1000.3  [Amended]

0
2. Revise Sec.  1000.3 by removing paragraph (s) and redesignating 
paragraphs (t) and (u) as paragraphs (s) and (t).

Subpart C--[Removed]

0
3. Remove subpart C, consisting of Sec. Sec.  1000.50, 1000.55, and 
1000.60.

PART 1002--RECORDS AND REPORTS

0
4. The authority citation for part 1002 continues to read as follows:

    Authority:  21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374.

0
5. Amend Sec.  1002.1 by revising table 1 to read as follows:


Sec.  1002.1   Applicability.

* * * * *
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BILLING CODE 4164-01-C


Sec.  1002.2  [Removed]

0
6. Remove reserved Sec.  1002.2.


Sec.  1002.13  [Amended]

0
7. Amend Sec.  1002.13 by removing paragraph (c).
0
8. Revise Sec.  1002.20 to read as follows:


Sec.  1002.20  Reporting of accidental radiation occurrences.

    (a) Manufacturers of electronic products shall, where reasonable 
grounds for suspecting that such an incident has occurred, report to 
the Director, Center for Devices and Radiological Health, all 
accidental radiation occurrences reported to or otherwise known to the 
manufacturer and arising from the manufacturing, testing, or use of any 
product introduced or intended to be introduced into commerce by such 
manufacturer. Reasonable grounds include, but are not necessarily 
limited to, professional, scientific, or medical facts or opinions 
documented or otherwise, that conclude or lead to the conclusion that 
such an incident has occurred.
    (b) Such reports shall be submitted electronically through Center 
for Devices and Radiological Health eSubmitter or addressed to Food and 
Drug Administration, Center for Devices and Radiological Health, ATTN: 
Accidental Radiation Occurrence Reports, Document Mail Center, 10903 
New Hampshire Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993-0002, 
and the reports and their envelopes shall be distinctly marked ``Report 
on 1002.20'' and shall contain all of the following information where 
known to the manufacturer:
    (1) The nature of the accidental radiation occurrence;
    (2) The location at which the accidental radiation occurrence 
occurred;
    (3) The manufacturer, type, and model number of the electronic 
product or products involved;
    (4) The circumstances surrounding the accidental radiation 
occurrence, including causes;
    (5) The number of persons involved, adversely affected, or exposed 
during the accidental radiation occurrence, the nature and magnitude of 
their exposure and/or injuries and, if requested by the Director, 
Center for Devices and Radiological Health, the names of the persons 
involved;
    (6) The actions, if any, which may have been taken by the 
manufacturer, to control, correct, or eliminate the causes and to 
prevent reoccurrence; and
    (7) Any other pertinent information with respect to the accidental 
radiation occurrence.
    (c) If a manufacturer:
    (1) Is required to report to the Director under paragraph (a) of 
this section and also is required to report under part 803 of this 
chapter, the manufacturer shall report in accordance with part 803; or
    (2) Is required to report to the Director under paragraph (a) of 
this section and is not required to report under part 803 of this 
chapter, the manufacturer shall:
    (i) Immediately report incidents associated with a death or serious 
injury in accordance with paragraphs (a) and (b) of this section; and
    (ii) Either immediately report incidents not associated with a 
death or serious injury individually or compile such incidents for 
submission in a quarterly summary report with tracking and trending 
analysis of that data in accordance with paragraphs (a) and (b) of this 
section. A manufacturer need not file a separate report under this 
section if an incident involving an accidental radiation occurrence is 
associated with a defect or noncompliance and is reported pursuant to 
Sec.  1003.10 of this chapter.

PART 1010--PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

0
9. The authority citation for part 1010 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 
371, 381.

0
10. Section 1010.4 is amended by revising paragraph (b) introductory 
text to read as follows:


Sec.  1010.4   Variances.

* * * * *
    (b) Applications for variances. If you are submitting an 
application for variances or for amendments or extensions thereof, you 
must submit an original copy by mail to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Applications for variance can also be submitted 
electronically through the Regulations.gov website under Docket Number 
FDA-2013-S-0610 as a new comment with an upload of the variance 
application materials.
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

0
11. The authority citation for part 1020 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371, 
381.

0
12. Section 1020.30 is amended by revising paragraph (d)(1) to read as 
follows:


Sec.  1020.30   Diagnostic x-ray systems and their major components.

* * * * *
    (d) * * *
    (1) Reports of assembly. All assemblers who install certified 
components shall file a report of assembly, except as specified in 
paragraph (d)(2) of this section. The report will be construed as the 
assembler's certification and identification under Sec. Sec.  1010.2 
and 1010.3 of this chapter. The assembler shall affirm in the report 
that the manufacturer's instructions were followed in the assembly or 
that the certified components as assembled into the system meet all 
applicable requirements of Sec. Sec.  1020.30 through 1020.33. All 
assembler reports must be on a form prescribed by the Director, Center 
for Devices and Radiological Health. Completed reports must be 
submitted to the purchaser and, where applicable, to the State agency

[[Page 12169]]

responsible for radiation protection within 15 days following 
completion of the assembly.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
13. The authority citation for part 1040 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 
371, 381.

0
14. Section 1040.10 is amended by revising paragraph (a) to read as 
follows:


Sec.  1040.10   Laser products.

    (a) Applicability. The provisions of this section and Sec.  
1040.11, are applicable to all laser products, except when:
    (1) Incorporation of an uncertified laser product intended to be 
used as a component or replacement for an electronic product--The 
provisions of this section and Sec.  1040.11 are not applicable to an 
uncertified laser product that is incorporated into an electronic 
product that is then certified by the manufacturer of such finished 
electronic product in accordance with Sec.  1010.2 of this chapter, 
when:
    (i) Such a laser product is either sold to a manufacturer of an 
electronic product for use as a component (or replacement) in such 
electronic product, or
    (ii) Sold by or for such a manufacturer of an electronic product 
for use as a component (or replacement) in such electronic product, 
provided that such laser product:
    (A) Is accompanied by a general warning notice that adequate 
instructions for the safe installation of the laser product are 
provided in servicing information available from the complete laser 
product manufacturer under paragraph (h)(2)(ii) of this section, and 
should be followed,
    (B) Is labeled with a statement that it is designated for use 
solely as a component of such electronic product and therefore does not 
comply with the appropriate requirements of this section and Sec.  
1040.11 for complete laser products, and
    (C) Is not a removable laser system as described in paragraph 
(c)(2) of this section; and
    (iii) The manufacturer of such a laser product, if manufactured 
after August 20, 1986:
    (A) Registers, and provides a listing by type of such laser 
products manufactured that includes the product name, model number and 
laser medium or emitted wavelength(s), and the name and address of the 
manufacturer. The manufacturer must submit the registration and listing 
to the Director, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G609, 
Silver Spring, MD 20993-0002. Alternatively, reports may be submitted 
electronically through Center for Devices and Radiological Health 
eSubmitter.
    (B) Maintains and allows access to any sales, shipping, or 
distribution records that identify the purchaser of such a laser 
product by name and address, the product by type, the number of units 
sold, and the date of sale (shipment). These records shall be 
maintained and made available as specified in Sec.  1002.31 of this 
chapter.
    (2) Incorporation of a certified laser product into another 
product--The provisions of this section and Sec.  1040.11 are 
applicable to a manufacturer of a laser product and are not applicable 
as specified to a manufacturer who incorporates such laser product 
manufactured or assembled after August 1, 1976, into another product, 
when:
    (i) The manufacturer of such incorporated laser product is not a 
laser product intended for use as a component or replacement as 
described in paragraphs (a)(1)(i) and (ii) of this section,
    (ii) The manufacturer of the incorporated laser product certifies 
such a laser product under Sec.  1010.2 of this chapter,
    (iii) The incorporated laser product is not modified as defined in 
paragraph (i) of this section,
    (iv) The incorporated laser product is installed in accordance with 
the instructions for the incorporated laser product as provided by the 
manufacturer of the incorporated laser product,
    (v) The manufacturer of the incorporating product provides with the 
incorporating product the user information required under paragraph (h) 
of this section,
    (vi) The labeling requirements of Sec. Sec.  1010.3 of this chapter 
and 1040.10(g) for the incorporated laser product would be met when the 
incorporated laser product is removed from the incorporating product,
    (vii) The labeling requirements of Sec.  1040.10(g) for the 
incorporated laser product would be met in any service configuration of 
the incorporated laser product, even when that incorporated laser 
product could be serviced without removal from the incorporating 
product, and
    (viii) The manufacturer of the incorporating product otherwise 
meets the requirements under this subchapter applicable to distributors 
of laser products (Sec. Sec.  1002.40 and 1002.41 of this chapter).
* * * * *

PART 1050--[REMOVED AND RESERVED]

0
15. Remove and reserve part 1050.

    Dated: March 19, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-05822 Filed 3-29-19; 8:45 am]
BILLING CODE 4164-01-P


