[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3638-3654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1000, 1002, 1010, 1020, 1030 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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
amending and repealing 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 taking 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regulatory requirements that are outdated and duplicate other means to 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.

DATES: This rule is effective February 21, 2023.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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. 3680, Silver Spring, MD 20993, 301-796-6661, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits of the Final Rule
II. Table of Abbreviations/Commonly Used Acronyms
III. Background
    A. Need for Amendments and Repeal of Certain Radiological Health 
Regulations
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
IV. Legal Authority
V. Comments to the Proposed Rule and FDA's Responses
    A. General Comments on the Proposed Rule
    B. Radiation Safety Recommendations/Standards Comments
    C. General Format and Edit Comments
    D. Records and Reports Comments
    E. Reports of Assembly, Forms, and Guidance Comments
    F. Accidental Radiation Occurrences Comments
    G. Laser Comments
VI. Effective Date
VII. 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 Final Rule

    This final rule amends and repeals certain regulations for 
radiation emitting electronic products and medical devices because the 
FDA has identified the regulations as being outdated and duplicative of 
other means for reducing radiation exposure to the public. The Agency 
is updating the regulations to amend or repeal 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 finalized for amendment or 
repeal 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 Final Rule

    This final rule updates FDA's radiological health regulations to 
amend or repeal the following provisions:
     Repeal the radiation protection recommendations that have 
become outdated and unnecessary;
     Removing or reducing some of the annual reports and test 
record

[[Page 3639]]

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 provide for 
quarterly reporting for AROs that are not associated with a death or 
serious injury;
     Amend the applications for variances processes 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;
     Amend the reporting requirements for manufacturers that 
incorporate a certified laser product to reduce reporting that is 
considered duplicative under certain conditions; and
     Repeal the performance standard for ultrasonic products 
because it is limited to a subset of physical therapy devices with an 
outdated standard.
    The Agency believes the amendments and repeals will help to 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 final 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). FDA has the authority under 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 rule.

D. Costs and Benefits of the Final Rule

    This final rule updates 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 $69.71 million at a 7 percent discount rate and $97.89 
million at a 3 percent discount rate. Annualized total cost savings are 
$6.58 million. We estimate the costs to read the rule for all reporting 
respondents. The present value costs are $1.60 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

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                         Abbreviation                                             What it means
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ARO...........................................................  Accidental Radiation Occurrences.
CDRH..........................................................  Center for Devices and Radiological Health.
CFR...........................................................  Code of Federal Regulations.
CRCPD.........................................................  Conference of Radiation Control Program
                                                                 Directors.
CT............................................................  Computerized Tomography.
EO............................................................  Executive Order.
EPRC..........................................................  Electronic Product Radiation Control.
EPA...........................................................  Environmental Protection Agency.
FD&C Act......................................................  Federal Food, Drug, and Cosmetic Act.
FDA, Agency or we.............................................  Food and Drug Administration.
ICRP..........................................................  International Commission on Radiological
                                                                 Protection.
IEC...........................................................  International Electrotechnical Commission.
ISO...........................................................  International Organization for Standardization.
MDR...........................................................  Medical Device Reporting.
NCRP..........................................................  National Council on Radiation Protection and
                                                                 Measurements.
OMB...........................................................  Office of Management and Budget.
PRA...........................................................  Paperwork Reduction Act of 1995.
TEPRSSC.......................................................  Technical Electronic Product Radiation Safety
                                                                 Standards Committee.
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III. Background

    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 Electronic Product Radiation Control (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, 
including professional guidelines that apply to the education and 
licensing of practitioners, as well numerous current radiation guidance 
documents and industry standards that practitioners and industry rely 
on to protect the public health and safety. For example, 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, 
Medical electrical equipment--Part 2-5: Particular requirements for the 
basic safety and essential performance of ultrasonic physiotherapy 
equipment (August 6, 2013) and 61689, Ultrasonics--Physiotherapy 
systems--Field specifications and methods of measurement in the 
frequency range 0.5 MHz to 5 MHz (January 30, 2014). FDA also 
recognizes that submission of certain quarterly reports is unnecessary 
given certain annual reporting requirements. In addition, the 
submission of initial product reports for products that are also 
subject to premarket authorization prior to marketing is duplicative. 
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, EPRC (sections 531-542 
of the FD&C Act (21 U.S.C. 360hh-360ss)). Under these provisions, FDA

[[Page 3640]]

administers the EPRC program to protect the public health and safety. 
This authority provides for developing, amending, and administering 
radiation safety performance standards for electronic products.
    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 and products (sections 514(c) (21 
U.S.C. 360d) and 531-542 of the FD&C Act). FDA believes radiation 
emitting electronic products and devices that comply with Federal 
standards and Federally-recognized consensus standards, adequately 
protect the public health and safety and provide a reasonable assurance 
of safety and effectiveness, as applicable, 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. 1, 2-4).
    In 2010, FDA's Center for Devices and Radiological Health (CDRH) 
launched an ``Initiative to Reduce Unnecessary Radiation Exposure from 
Medical Imaging'' (Ref. 3) 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 healthcare 
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. 4).
    In accordance with FDA's directive to carry out the EPRC program 
(see sections 532, 534(a)(1), and 537(b) of the FD&C Act), FDA 
prescribes and amends performance standards for electronic products to 
control the emission of electronic product radiation when necessary to 
protect the public health and safety. In establishing performance 
standards consistent with the statute, FDA consulted with the Technical 
Electronic Product Radiation Safety Standards Committee (TEPRSSC) 
(section 534(f) of the FD&C Act) (Ref. 5). 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 (Ref. 5). 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 amendments have been 
considered in discussions by TEPRSSC as necessary. Therefore, 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.

A. Need for Amendments and Repeal of Certain Radiological Health 
Regulations

    Many of the requirements in our radiological health regulations are 
over 30 years old. As described below and in the proposed rule (84 FR 
12147, April 1, 2019) the final rule amends and repeals certain 
radiological health regulations to reduce regulatory requirements that 
are outdated and duplicative. Specifically, this final rule amends 
parts of the radiological health regulations covering recommendations 
for radiation protection during medical procedures, certain records and 
reporting for electronic products, applications for variances, and 
performance standards for diagnostic x-ray systems and their major 
components, laser products, and ultrasonic therapy products while still 
assuring the public health and safety is protected against harmful 
exposure to radiation emitting electronic products and medical devices.

B. Summary of Comments to the Proposed Rule

    In the Federal Register of April 1, 2019, FDA published a proposed 
rule to amend the radiological health regulations (84 FR 12147). The 
comment period for the proposed rule closed on July 1, 2019. FDA 
received comments on the proposed rule from several entities including 
medical device associations, industry, medical and healthcare 
professional associations, public health advocacy groups, and 
individuals. While some comments object to particular sections or 
subsections of the proposed rule, almost all comments voice support for 
the objective intent of the proposed rule, to amend certain regulations 
to reduce regulatory burden while continuing to assure protection of 
the public health and safety against harmful exposure to radiation 
emitting electronic products and medical devices.
    Some comments raise concerns or request clarification regarding:
     repealing the radiation protection recommendations,
     removing or reducing certain records and reporting 
requirements for electronic products,
     incorporating and expanding the policies described in 
FDA's Laser Notice 42 to higher powered laser products,
     amending the performance standards for laser products that 
incorporate certified laser systems,
     information on future technologies and other measures that 
may reduce or eliminate radiation exposure,
     document retention and responsibilities related to 
initial, supplemental, abbreviated and annual reports,
     assemblers' responsibilities for maintaining a record of 
report of assembly on file,
     the tracking and trending analysis related to the 
requirements for reports on accidental radiation occurrences, and
     additional amendments to performance standards for laser 
products.

C. General Overview of Final Rule

    FDA considered all comments received on the proposed rule and made 
changes, primarily for clarity and accuracy and to be consistent with 
the goal of reducing the burden of regulatory requirements for 
radiation emitting products and medical devices without compromising 
patient safety. On its own initiative, FDA is also making minor 
technical changes to improve clarity and consistency and reduce 
regulatory burden. Based on the comments received on the proposed rule, 
FDA has made changes from the proposed rule (84 FR 12147) to include 
the following revisions in the codified section of this final rule:
     Include the word ``accidental'' in the definition for 
radiation occurrence (Sec.  1000.3(a)),
     include a footnote in the records and reports table 
clarifying laser product certification (table 1 in Sec.  1002.1),

[[Page 3641]]

     include language of information needed for quarterly 
reporting of accidental radiation occurrences (Sec.  
1002.20(c)(2)(ii)),
     include a paragraph with language to identify when 
certification and reporting is duplicative and unnecessary for laser 
products under Sec.  1040.10 that incorporate a certified laser system 
(Sec.  1010.2(e)),
     identify an alternative format for identification of the 
month and date of the manufacture of an electronic product (Sec.  
1010.3(a)(2)(ii)),
     clarify the options for submissions for applications for 
variances (Sec.  1010.4(b)(1)), and
     revise the title and applicability for television 
receivers that contain a cathode ray tube (Sec.  1020.10).
    FDA also decided on its own initiative to include the following 
additional amendments to this final rule for clarity and consistency 
and to reduce regulatory burden:
     remove the requirement for two copies of an application 
for exemption of warning labels for a microwave oven that are submitted 
to CDRH and correct the name of the CDRH office to submit a document 
(Sec.  1030.10(c)(iv)), and
     clarify and remove the requirement that x-ray assemblers 
for certified accessory components submit Reports of Assembly (Form FDA 
2579) to CDRH (Sec.  1020.30(d)(2)).

IV. Legal Authority

    FDA is issuing this final 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 final rule.

V. Comments on the Proposed Rule and FDA's Responses

    We received several sets of comments on the proposed rule by the 
closure of the comment period, each containing one or more comments on 
one or more issues. We received comments from medical device 
associations, industry, medical and healthcare professional 
associations, public health advocacy groups, and individuals. We 
describe and respond to the comments in this section of the document. 
The topics for the comments are grouped based on the common themes 
identified below. We have grouped similar comments together under the 
same number so that FDA's responses could be addressed by topic, 
instead of each comment addressed independently, and, in some cases, we 
have separated different issues discussed in the same comment and 
designated them as distinct comments for purposes of our responses. The 
number assigned to each comment or comment topic is purely for 
organizational purposes and does not signify the comment's value or 
importance or the order in which comments were received.

A. General Comments on the Proposed Rule

    (Comment 1) FDA received multiple comments that express support for 
the proposed rule and the proposals to remove outdated radiation 
protection recommendations and adjust the regulatory records and 
reporting requirements based on risk. The comments urged the Agency to 
maintain vigilance and continue to promote the health and safety of 
patients and healthcare practitioners.
    (Response 1) FDA appreciates the public support for the rule. FDA 
intends to continue to utilize its regulatory authorities and 
collaborations with other governmental agencies, non-governmental 
organizations, and industry, among others, to promote the safe and 
effective use of radiation to best protect and promote public health.

B. Radiation Safety Recommendations/Standards Comments

    (Comment 2) One comment referenced multiple publications that 
supported FDA's proposal that the recommendations in Sec.  1000.50 for 
use of gonad shielding were inconsistent with current scientific 
evidence and should be removed.
    (Response 2) FDA agrees with the recommendation and is removing the 
recommendations in Sec.  1000.50 in this final rule.
    (Comment 3) One comment raised concern that by repealing the 
radiation protection recommendations, end-users may have difficulty 
finding, analyzing, and applying the appropriate standards and 
practices to specific clinical healthcare situations. The comment 
requested that FDA list the specific regulations that are outdated or 
duplicative and provide direction as to the appropriate current 
standards or practice parameters that replace the repealed regulations.
    (Response 3) FDA acknowledges the concern but does not believe that 
repeal of the recommendations will cause difficulty in locating and 
applying applicable standards and practices. This final rule identifies 
the Sec.  1000.50 recommendations that are being removed. FDA believes 
these specific recommendations are outdated and no longer relied upon 
by healthcare providers. Removing the recommendations eliminates 
information that is no longer useful. FDA identified recent, consensus 
recommendations in the proposed rule (Refs. 1, 2, 6-9). FDA continues 
to recommend that medical professionals also seek continuing education 
through professional societies to remain current with new technologies, 
standards, and best practice guidelines.
    (Comment 4) Multiple comments recognized the contributions of 
external stakeholders to develop and incorporate radiation protection 
into device design, practitioner training, and best practices for 
standards of care. Comments stated that diagnostic imaging is an 
important part of the standard of care, and training and continuing 
education are important so that healthcare professionals know the 
rules, regulations, safety procedures, and best practices to benefit 
patients and avoid harm. The comments requested that FDA support and 
reference the most relevant guidelines for healthcare professionals 
wherever feasible.
    (Response 4) FDA recognizes the importance of training and 
continuing education for healthcare professionals and will continue to 
collaborate with, and reference the work of, external organization as 
appropriate to develop standards. FDA believes professional societies 
should have the resources and knowledge to provide the most up-to-date 
guidelines for their members. 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. For example, in 2003, the National 
Council on Radiation Protection and Measurements (NCRP) updated its 
recommendations on radiation protection in dentistry (Ref. 6). In 2012, 
the American Dental Association, in conjunction with FDA, updated its 
selection criteria for dental imaging with guidelines for the frequency 
of

[[Page 3642]]

dental radiographs and radiation exposure recommendations (Ref. 7). 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. 3), which provides comprehensive recommendations for 
radiation protection to medical and dental facilities (Ref. 1). Because 
safety procedures and best practices are continuously revised and 
improved, FDA believes that specifically referencing existing 
guidelines in the regulations is not appropriate because it may lead to 
confusion or unintended consequences as practice guidelines continue to 
be updated.
    (Comment 5) One comment acknowledges that professional 
organizations play a key role in developing guidance for safe use of 
radiation, but such guidance may not be comprehensive. The comment 
recommended that FDA define the organizational credentials and 
processes to guide the development and format of radiation use 
standards.
    (Response 5) FDA disagrees with the recommendation because the EPRC 
does not provide for defining and enforcing criteria by which standards 
organizations or professional societies operate (see sections 532, 
534(a)(1), and 537(b) of the FD&C Act). FDA's standards program 
provides FDA with the opportunity to review and rely on appropriately 
developed standards within the scope of the FD&C Act. FDA actively 
participates in the development of voluntary standards and guidelines 
with other organizations. FDA encourages individuals and professional 
societies to join and participate in the development of safety 
recommendations and standards to address the diversity of clinical, 
scientific, and other needs that apply to their profession.
    (Comment 6) One comment suggested that one national set of 
standards, regulations and training requirements for operators is 
preferable to differences by state or locality. The comment included a 
specific example that the quality of dental radiography may vary given 
the lack of national requirements, especially with the introduction of 
new technologies, such as cone-beam Computerized Tomography (CT). The 
lack of a national standard may result in different approaches to 
radiographer training, with the potential for increased radiation 
exposure to patients. The comment recommended that FDA designate a 
specific organization as the responsible entity on all aspects of 
dental imaging including training of all dental personnel who perform 
dental imaging examinations.
    (Response 6) FDA disagrees with the recommendation. The EPRC does 
not provide for defining and enforcing criteria by which standards 
organizations or professional societies operate, or for designating an 
organization(s) to define or enforce such requirements. FDA notes that 
such standards and training are generally provided for by appropriate 
organizations and professions, and FDA frequently collaborates with 
these organizations and professions. FDA supports the continuation of 
such efforts by these entities to educate members on best practices for 
safe use of radiation in their profession. For dental imaging 
specifically, FDA, in collaboration with the Conference of Radiation 
Control Program Directors (CRCPD), recently completed a nationwide 
survey of the use of radiation in dental imaging facilities (Ref. 10). 
FDA staff participated in developing a report by the National Council 
on Radiation Protection and Measurements (NCRP) on radiation protection 
in dentistry (Ref. 11). FDA has also collaborated with the American 
Dental Association on guidelines for the selection of patients for 
dental radiographic examinations (Ref. 7). FDA hopes the results of 
these kinds of collaborations, and other work from similar 
organizations, will help inform FDA and other organizations of best 
practices and recommendations for training and equipment standards.
    (Comment 7) One comment recommended FDA withdraw the rules and 
regulations for the lowest risk radiation emitting electronic products 
first. The commenter suggested removing reporting of assembly for wall 
mounted x-ray generators for intraoral radiography, while maintaining 
reporting for handheld portable x-ray generators for use in dentistry, 
which are relatively new and without the same safety record.
    (Response 7) FDA disagrees with the comment. FDA has taken a risk-
based assessment in amending the regulations. FDA considers submission 
to FDA of any report of assembly for certified components of diagnostic 
x-ray products to no longer be necessary, while continuing to 
facilitate the submission of such reports of assembly, where 
applicable, to State agencies and purchasers. Diagnostic x-ray systems 
still need to meet the product-specific performance standards under 
part 1020 (21 Code of Federal Regulations (CFR), part 1020), including 
the submission of any reports of assembly of installed certified 
components as applicable. Diagnostic x-ray systems, including handheld 
dental x-ray units, will also continue to be subject to applicable 
medical device regulations (see, e.g., 21 CFR parts 803, 807, 820, 872, 
and 892).
    (Comment 8) Some comments support the use of international 
voluntary consensus standards to help ensure regulatory requirements 
are met. Commenters noted the benefits, including consistency in 
regulation, global harmonization, efficiencies, minimizing unnecessary 
costs and delays in patient access to innovative new devices and 
promoting safety, and consistency with the National Technology Transfer 
and Advancement Act (Pub. L. 104-113), and Office of Management and 
Budget's (OMB) directive Circular A-119, Federal Participation in the 
Development and Use of Voluntary Consensus Standards and in Conformity 
Assessment Activities (Ref. 12).
    (Response 8) FDA agrees with these comments and will continue to 
participate in the development of international standards and their use 
for regulatory purposes as appropriate.
    (Comment 9) One comment expressed interest in FDA providing 
information on future technologies and other measures that may reduce 
or eliminate radiation exposure.
    (Response 9) FDA recommends that medical professionals seek 
continuing education through their appropriate professional societies 
to maintain knowledge of new technologies and best practice guidelines. 
With respect to medical devices, FDA's Q-Submission Program (Ref. 13) 
offers manufacturers the opportunity to receive feedback on their 
proposed regulatory pathway and test plans when developing new devices 
and technologies that may improve image quality and patient safety.

C. General Format and Edit Comments

    (Comment 10) One comment recommended reformatting table 1 of Sec.  
1002.1 for clarity by merging and shading the category rows.
    (Response 10) FDA understands the concern for readability of the 
regulations; however, FDA is limited in the formatting tools available 
for display and printing of regulations in the Federal Register and the 
CFR, as such stylistic issues are determined by the U.S. Government 
Publishing Office for the entire Federal government. The information 
will continue to be displayed in table 1 as formatted and published in 
the proposed rule.
    (Comment 11) One comment recommended clarifying in Sec. Sec.  
1002.20(b) and 1010.4(b) whether

[[Page 3643]]

submission of both electronic and paper reports and variance requests 
are acceptable.
    (Response 11) FDA agrees with the recommendation and is revising 
the language in Sec. Sec.  1002.20(b) and 1010.4(b) to clarify that 
``either'' electronic or paper submissions are appropriate.
    (Comment 12) One comment recommended that the regulations allow for 
use of the International Organization for Standardization (ISO) 
standard date format (``YYYY-MM-DD''), which is required for medical 
devices in 21 CFR 801.18(a), as an alternative to the EPRC format 
specified in Sec.  1010.3(a)(2)(ii).
    (Response 12) FDA agrees with the recommendation and is revising 
the regulation to alternatively provide for use of a manufacturing 
symbol and date format that is in accordance with applicable FDA 
recognized consensus standards, such as ISO 7000: Graphical symbols for 
use on equipment and IEC 60417: Graphical symbols for use on equipment 
(Ref. 14) (see Sec.  1010.3(a)(2)(ii) of this final rule).

D. Records and Reports Comments

    (Comment 13) One comment requested clarification of the document 
retention requirements related to initial (Sec.  1002.10), supplemental 
(Sec.  1002.11), abbreviated (Sec.  1002.12), and annual reports (Sec.  
1002.13). The Agency was asked to state clearly that manufacturers will 
no longer need to generate and retain these reports.
    (Response 13) The proposed rule modified table 1 (Sec.  1002.1) to 
show that manufacturers of diagnostic x-ray products would no longer 
need to submit initial (Sec.  1002.10), supplemental (Sec. Sec.  
1002.11), abbreviated (Sec.  1002.12), and annual reports (Sec.  
1002.13). In the final rule, we are maintaining this change. As a 
result, manufacturers of diagnostic x-ray systems will no longer need 
to generate and retain such reports related to diagnostic x-ray 
systems. To clarify, this modification would not remove these 
requirements for all products listed under table 1 (Sec.  1002.1 of 
this final rule). Many other reporting and recordkeeping requirements 
are unchanged including, as applicable based on the requirements in 
Sec.  1002.1, the requirements for test and distribution records 
specified in Sec.  1002.30.
    (Comment 14) One comment requested that FDA clarify if an annual 
report would still be required for a diagnostic x-ray system that falls 
within this category due to its display being classified as a 
television product (Sec.  1020.10). The comment suggested removing the 
reporting requirements for such displays that are included in 
diagnostic x-ray systems.
    (Response 14) FDA appreciates the comment and recognizes there may 
be confusion about reporting requirements for diagnostic x-ray systems 
that include television displays. FDA agrees that reporting should not 
be required for medical device manufacturers of diagnostic x-ray 
systems that use modern display technologies (e.g., light emitting 
diode and liquid crystal display) that do not incorporate a cathode ray 
tube display. However, FDA believes that the reporting requirement 
should be maintained for displays that do contain a cathode ray tube, 
and were manufactured subsequent to January 15, 1970, because these 
types of displays generate ionizing radiation during use. FDA is 
therefore amending Sec.  1020.10(a) to clarify that the television 
product performance standard (and thus reporting requirements) only 
applies to televisions/displays that contain a cathode ray tube. FDA 
believes EPRC reporting for such older technologies is necessary for 
the public health and safety to monitor the use of cathode ray tubes in 
televisions/displays. Given the outdated nature of the cathode ray tube 
technology, at this time, FDA believes this type of television display 
included in diagnostic x-ray systems is the only type that would 
continue to benefit from the annual reporting requirement. Therefore, 
FDA does not believe that excluding this type of television display 
product from the reporting requirements is appropriate at this time.
    (Comment 15) One comment requested FDA to clarify how the changes 
in reporting would impact the process for manufacturers to receive 
accession numbers, which are used for customs clearance.
    (Response 15) Manufacturers of diagnostic x-ray systems that are no 
longer required to submit product reports, and who therefore will no 
longer receive an accession number, will no longer need to submit an 
accession number when importing products (see Sec.  1002.1, table 1 of 
this final rule). The import process for diagnostic x-ray systems will 
be the same as for other medical devices that do not require submission 
of product reports. Manufacturers can refer to FDA's website for more 
information on the imports process and program (Ref. 15).
    (Comment 16) One comment mentioned the concern that if the records 
and reporting requirements for electronic products and medical devices 
are removed or reduced, then end-users will rely on state requirements, 
which may not have changed in many years. The comment raised concerns 
that in some states, repealing regulations for records and reporting 
requirements for electronic products and medical devices may be 
catastrophic if a recall on ionizing radiation equipment were issued.
    (Response 16) FDA believes recordkeeping is important in case of 
recalls and that compliance with all applicable performance standards 
is important to ensure the protection of the public health and safety. 
The amendments do not change FDA's authority or a manufacturer's 
responsibilities if a product is defective or fails to comply with 
performance standards under section 534 of the FD&C Act. The final rule 
does not change any of the manufacturer, dealer, or distributer 
recordkeeping requirements under Sec. Sec.  1002.1, 1002.30, 1002.40, 
or 1002.41 that are used to notify potentially impacted persons. The 
final amendments also do not change the reporting, notification, and 
requirements to perform corrective actions under part 1003 (21 CFR part 
1003) for electronic product defects or failure to comply with a 
performance standard. Lastly, the amendments do not change any of the 
regulations applicable to the recall of medical devices under 21 CFR 
part 806. Therefore, FDA disagrees that it would be catastrophic if a 
recall on ionizing radiation equipment were issued following these 
amendments.

E. Reports of Assembly, Forms, and Guidances Comments

    (Comment 17) Some comments supported amending the regulations to no 
longer require assemblers who install certified accessory components of 
diagnostic x-ray systems to submit reports of assembly (Form FDA 2579) 
to FDA.
    (Response 17) FDA agrees with the comment. In this rulemaking, FDA 
is removing the requirement to submit a copy of Form FDA 2579 to FDA. 
Assemblers will still be required to submit a copy to the purchaser, 
and, where applicable, to state agencies responsible for radiation 
protection.
    (Comment 18) One comment requested clarification on whether FDA 
will continue to make available Form FDA 2579 for manufacturers to use 
for submitting to states and purchasers. A comment also suggested that 
the form be made available in a PDF fillable format and that it retain 
a document control number field.
    (Response 18) FDA agrees with this request and is revising Sec.  
1020.30(d)(1) to specify that Form FDA 2579 is available online. FDA 
intends to make the form

[[Page 3644]]

PDF fillable and retain a field on the form for a document control 
number. However, FDA does not intend to generate or specify the format 
of document control numbers.
    (Comment 19) One comment asked if the Agency will generate and/or 
require a unique document control number for each report of assembly, 
with a suggestion that manufacturers could develop a unique 
identification format for the document control numbers.
    (Response 19) At this time, FDA will not generate document control 
numbers or define the format that manufacturers utilize. Manufacturers 
are welcome to develop a standardized scheme for the document control 
number if they wish.
    (Comment 20) One comment requested FDA to clarify if manufacturers 
will need to keep a record of the report of assembly on file.
    (Response 20) Assemblers, including manufacturers who are 
assembling diagnostic x-ray equipment, subject to the provisions of 
Sec.  1020.30(d) will still be required under Sec.  1002.1(c)(4) to 
maintain a copy of the report of assembly for 5 years.
    (Comment 21) One comment requested FDA to specify what reporting 
guides, forms, and guidance will be removed from the FDA website.
    (Response 21) The Paperwork Reduction Act (PRA) section of this 
final rule (section IX) identifies what forms will be removed or 
amended. The publication of the final rule coincides with updates to 
relevant FDA guidance documents for consistency with the amended 
regulations.
    (Comment 22) Several commenters sought clarity on reporting and 
recordkeeping responsibilities associated with the changes in the 
proposed rule, including any need to document reliance on recognized 
consensus standards for diagnostic x-ray systems. While commenters 
understood some reports and forms that would no longer need to be 
submitted to FDA, there was uncertainty regarding certain requirements 
to generate and maintain test records and document compliance with the 
standards.
    (Response 22) Manufacturers will no longer need to generate certain 
specific reports to submit to FDA. In finalizing the rule, FDA is 
withdrawing the reporting guides for reports that are no longer 
required to be submitted. Manufacturers will still need to maintain 
test and distribution records (Sec.  1002.30), where applicable. If a 
manufacturer chooses to conform to applicable recognized IEC standards 
in lieu of conforming to the performance standards as described in FDA 
guidance (Ref. 16), then manufacturers must include in their test 
records documentation specific to the scope of the corresponding 
standards.

F. Accidental Radiation Occurrences Comments

    (Comment 23) Several comments supported quarterly submission for 
AROs that are not associated with a death or serious injury. One 
comment suggested that the regulations be further amended so that 
manufacturers of medical devices that are also electronic products only 
need to comply with the Medical Device Reporting (MDR) requirements.
    (Response 23) ARO reporting is critical for FDA to meet its 
responsibility to identify and reduce unnecessary sources of radiation 
exposure to the public for medical and non-medical devices. Medical 
device manufacturers are required to report once they are aware of 
information that reasonably suggests the medical device may have caused 
or contributed to death or serious injury or there is a malfunction 
that, if it were to recur, is likely to cause or contribute to a 
serious injury or death (part 803 (21 CFR part 803)). Medical devices 
that also meet the definition of an electronic product must also comply 
with the ARO reporting requirements in Sec.  1002.20, which requires 
manufacturers to report a single event, or series of events, that 
resulted in injurious or potentially injurious exposure of any person 
to electronic product radiation as a result of a malfunction due to the 
manufacturing, testing, or use of an electronic product. The ARO 
reporting program is intended to capture both serious malfunctions that 
require immediate action to prevent future death or injury (which 
overlaps with MDRs) and less-serious events (which may not overlap with 
MDRs) where periodic reporting would help identify unnecessary 
radiation exposure that may be addressed through manufacturer 
correction or through revisions to safety standards. For this reason, 
FDA believes ARO reporting requirements should be maintained even when 
the product is subject to part 803 reporting requirements to ensure the 
protection of the public health and safety under the EPRC program.
    (Comment 24) One comment requested that FDA amend the regulations 
to state that instances in which an exposure made by a healthcare 
professional that is deemed to be clinically necessary is not an ARO 
even when it is a repeat scan or image caused by a system interruption.
    (Response 24) The term ``accidental radiation occurrence'' under 
Sec.  1000.3(a) includes two essential aspects to such an event. First, 
electronic product radiation must have been emitted. For ionizing 
radiation, FDA considers the use of the linear no-threshold model 
(i.e., a threshold below the amount of ionizing radiation that is not 
``potentially injurious'') (Ref. 17) as a prudent and practical 
approach for radiation protection. Second, the radiation emission must 
have been accidental, by which the Agency means that the emission was 
unintended and unexpected. An intended and expected radiation emission, 
such as an intentional repeat scan or image, does not meet the 
criterion of ``accidental'' and is not an ARO. To improve clarity on 
this distinction, FDA is amending the definition of an ARO (Sec.  
1000.3(a) in this final rule) to include the word ``accidental'' within 
the definition to more clearly indicate that an ARO is an accidental 
event resulting in radiation exposure. With this clarification, FDA 
does not believe it is necessary to further amend the regulation by 
providing specific examples involving radiation occurrences that are 
not considered to be accidental.
    (Comment 25) A few comments asked FDA to clarify how the tracking 
and trending analysis relates to the requirements in Sec.  1002.20(a) 
and (b) and what would be expected as part of this new requirement.
    (Response 25) FDA acknowledges there may be confusion regarding how 
the quarterly summary reporting with tracking and trending analysis 
relates to the requirements under Sec.  1002.20(a) and (b). FDA is 
therefore amending Sec.  1002.20 to clarify that: (1) the quarterly 
report must include information required under Sec.  1002.20(b)(1) 
through (7) for each occurrence where known to the manufacturer, (2) 
that accidental radiation occurrences may be grouped to identify the 
most common circumstances and potential cause(s), including but not 
limited to, design changes, manufacturing, or user, and (3) that 
planned mitigation(s) with an assessment of effectiveness, or a 
justification for why mitigation is not necessary, must be associated 
with each occurrence or grouping of similar occurrences (see Sec.  
1002.20(c)(2)(ii) in this final rule). Such incidents should also be 
evaluated to determine if the accidental radiation occurrence is the 
result of a defect as defined in Sec.  1003.2 of this chapter or fails 
to comply with an applicable Federal standard (see Sec.  1003.10). 
Medical device manufacturers may be able to rely on information already 
being generated as

[[Page 3645]]

part of their corrective and preventive actions (21 CFR 820.100).
    (Comment 26) A few comments asked FDA to clarify if the tracking 
and trending analysis applied to both immediate reports and quarterly 
reports.
    (Response 26) The submission of the tracking and trending analysis 
only applies to quarterly reporting.

G. Laser Comments

    (Comment 27) Several comments stated that the proposed amendments 
to Sec.  1040.10 were confusing and should be clarified. The comments 
raised concerns about creating a circular logic path between the text 
proposed in Sec.  1040.10(a)(1), which indicates the standard is not 
applicable to an uncertified laser product that is incorporated into an 
electronic product that is then certified by the manufacturer, and the 
certification requirements in Sec.  1010.2(a), which requires 
certification when the performance standard is applicable. Commenters 
stated that the term ``uncertified'' in proposed Sec.  1040.10(a)(1), 
along with other edits, caused confusion because certain aspects of the 
standard appeared to be required/applicable, while certification was 
not required.
    Multiple comments recommended that FDA either: (1) revise or keep 
the original language of certain paragraphs in Sec.  1040.10, with 
removal or modifications to specific sections for clarity or (2) keep 
the existing language in Sec.  1040.10(a) and instead modify Sec. Sec.  
1002.1(c), 1010.2, and 1010.3, which would have the effect of 
Sec. Sec.  1040.10 and 1040.11 still being required even if 
certification, identification, and manufacturer's reports are not 
required.
    (Response 27) FDA agrees with the latter recommended approach (#2) 
to keep the existing language in Sec.  1040.10, and instead amend Sec.  
1002.1 in table 1 and Sec.  1010.2, consistent with the amendments in 
the proposed rule, to clarify when and under what conditions reporting 
would not need to be duplicated. In those situations, the manufacturers 
would be considered distributors of certified laser products, and only 
subject to the applicable distribution recordkeeping requirements under 
Sec. Sec.  1002.40 and 1002.41 for the certified products (see Sec.  
1002.1, table 1, fn. 9 in this final rule). Also, we are revising Sec.  
1010.2 to identify the conditions under which a manufacturer could 
incorporate a certified laser product without the requirement to re-
certify or re-report the product (see Sec.  1010.2(e) of this final 
rule).
    (Comment 28) Some comments raised concerns that the proposed 
language in Sec.  1040.10(a)(2) did not clearly require products to 
comply with the performance standards after a certified laser was 
incorporated.
    (Response 28) The intent of the modifications in the proposed rule 
was to avoid duplicative reporting of information from manufacturers 
who incorporate a certified laser system into a product. The certified 
laser system, and the product into which it is incorporated, would 
still be required to conform with the performance standards. Products 
that incorporate a certified laser product are still required to comply 
with the FDA's performance standards. To clarify this, we are revising 
Sec.  1010.2 to clearly identify under what conditions a product that 
incorporates a certified laser system would be considered certified, 
and thus not need to be re-certified. In this final rule, all of the 
following conditions must be met: (1) the incorporated laser system is 
not a laser product intended for use as a component or replacement as 
described in Sec.  1040.10(a)(1) and (2); (2) the manufacturer of the 
incorporated laser system certifies such laser system and meets the 
reporting requirements under Sec.  1002; (3) the product incorporating 
the certified laser system is not independently subject to additional 
reporting or performance standards requirements; (4) the incorporated 
laser system is not modified as defined in Sec.  1040.10(i), and all 
performance features that apply to the incorporated laser system under 
Sec.  1040.10(f) are available on the product incorporating the 
certified laser system; (5) all labeling requirements that apply to the 
incorporated laser system under Sec. Sec.  1010.2, 1010.3, 1040.10(g), 
and 1040.11(a)(3) are visible on the outside of the product 
incorporating the certified laser system, with the exception that the 
certification or identification labels need not be visible on the 
outside of products incorporating a certified Class I laser; (6) the 
incorporated laser system is installed in the product in accordance 
with the instructions provided by the manufacturer of the incorporated 
laser system, including instructions for placing additional externally 
facing labels found in subsection (v), and meeting the other conditions 
in the subsections; (7) the manufacturer of the product that 
incorporates the laser system provides the end user with information 
required under Sec.  1040.10(h)(1) as provided to them by the 
manufacturer of the incorporated laser system; and (8) the labeling 
requirements under part 1010 and Sec.  1040.10(g) for the incorporated 
laser system would be met in any service configuration of the product 
incorporating the laser system or when the incorporated laser system is 
removed from the product into which it has been incorporated, and 
reproductions of such labels are found in the user information. 
Manufacturers of products that do not meet these conditions would need 
to certify and report the product that incorporates the certified laser 
system based on the class of the laser product as described in Sec.  
1002.1.
    (Comment 29) One comment raised concerns regarding the criteria for 
the incorporated laser system to be installed in accordance with the 
instructions provided by the manufacturer of the incorporated laser 
system. The comment stated that it would be difficult for the 
manufacturer of the incorporated laser system to foresee all potential 
installation options by other manufacturers.
    (Response 29) FDA does not expect the manufacturer of an 
incorporated laser system to foresee all potential installation 
options. FDA expects that a manufacturer planning to market a laser 
product specifically to be certified and incorporated into other 
systems would identify and specify any installation options and 
requirements, while taking into consideration how reasonable variations 
in the installation instructions should be provided to customers to 
ensure the conditions in Sec.  1010.2(e) are met. However, ultimately, 
the manufacturer of the incorporated laser system is responsible for 
ensuring their finished product is in compliance with all applicable 
regulatory requirements when certified and marketed. The manufacturer 
of the product incorporating the laser system is responsible for 
complying with the conditions in Sec.  1010.2(e). Otherwise, those 
manufacturers would need to complete the certification, reporting, and 
other applicable laser product requirements under Sec. Sec.  1002 and 
1040.10. For example, if the installation instructions would result in 
the laser product not meeting the conditions under Sec.  1010.2(e) 
(e.g., instructions that would result in a required safety interlock 
being unavailable), then the product incorporating the certified laser 
would not be considered to have met the certification requirements 
because all conditions in Sec.  1010.2(e) must be met.
    (Comment 30) FDA received comments expressing concern with the 
incorporation into regulation the policies described in FDA's Laser 
Notice 42, including expansion of those policies into regulation for 
higher

[[Page 3646]]

powered laser products without the requirements that the products 
incorporating higher power lasers comply with the performance 
standards. A commenter questioned whether the reporting requirements 
and performance standard would be applicable to a product that 
incorporated a certified Class I laser along with an uncertified Class 
IV laser, and if the labeling or safety features of the final product 
would need to meet the Class IV performance standards. Similar comments 
recommended that FDA revise and extend policies of Laser Notice 42 for 
clarity with additional requirements to ensure safety of higher class 
products.
    (Response 30) As noted in Response 28, this final rule is revising 
Sec.  1010.2 to identify under what conditions a product that 
incorporates a certified laser system would be considered to have met 
the certification requirements. There are several conditions, all of 
which must be met, including that the product incorporating the 
certified laser system must not be independently subject to additional 
reporting requirements or performance standards (see Sec.  
1010.2(e)(iii) in this final rule). FDA added this clarification to the 
revisions under Sec.  1010.2(e) of this final rule to ensure higher 
class products will continue to be subject to any applicable 
certification requirements, despite the incorporated laser system 
having met the certification requirements. For example, a Class IV 
laser product that incorporates a certified Class I laser does not meet 
the conditions in Sec.  1010.2(e)(iii), as additional certification and 
reporting requirements associated with the Class IV laser still apply. 
In addition, the incorporated laser system must not be modified, as 
defined in Sec.  1040.10(i), and all performance features that apply to 
the incorporated laser system under Sec.  1040.10(f) must be available 
on the product incorporating the certified laser system (see Sec.  
1010.2(e)(iv) in this final rule). All labeling requirements that apply 
to the incorporated laser system under Sec.  1040.10(g) must be visible 
on the outside of the product incorporating the certified laser system, 
with the exception that the certification or identification labels need 
not be visible on the outside of products that incorporate a certified 
Class I laser (see Sec.  1010.2(e)(v) in this final rule). The 
incorporated laser system must be installed in accordance with the 
instructions provided by the manufacturer of the incorporated laser 
system, including ensuring any required safety features or labeling are 
available (see Sec.  1010.2(e)(vi) in this final rule). The 
manufacturer of the product incorporating the laser system must also 
provide the end user with laser safety information as provided to them 
by the manufacturer of the incorporated laser system (see Sec.  
1010.2(e)(vii) in this final rule). In addition, the labeling 
requirements in part 1010 and Sec.  1040.10(g) for the incorporated 
laser system must be met in any service configuration of the product 
that incorporates the laser system, including when the incorporated 
laser system is removed from the product into which it has been 
incorporated, and reproductions of such labels must be included in the 
user information (see Sec.  1010.2(e)(viii) in this final rule).
    (Comment 31) One comment recommended limiting the amendments only 
to the lowest class of laser products; or a subset of classes with 
additional clarification to address the visibility of the warning logo 
type and aperture label; or all classes with clarifications about the 
difference between ``attaching'' versus ``assembling in, embedding in, 
or otherwise incorporating'' a laser or laser system.
    (Response 31) FDA believes that the revisions to Sec. Sec.  1002.1 
and 1010.2(e) that are being made in this final rule make it 
sufficiently clear that the manufacturer of the product incorporating 
the certified laser must not make modifications that would alter the 
availability of safety information or compliance with the standard if 
they wish to maintain the certification. FDA has added clarification to 
the revisions under Sec.  1010.2(e)(v) and (vi) of this final rule to 
ensure that visibility of certain labeling requirements that apply to 
the incorporated laser system continue to be maintained. Any 
modifications that would modify the class of laser, compliance with the 
performance standard, visibility of required labeling, or accessibility 
to required safety information would not meet the conditions of Sec.  
1010.2(e) and the product would no longer be considered certified--
meaning the manufacturer of the product incorporating the laser would 
need to complete the applicable certification and reporting 
requirements (see also Response 29).

VI. Effective Date

    This rule is effective 30 days after the date of publication in the 
Federal Register.

VII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive 
Order (E.O.) 12866, E.O. 13563, 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). We believe that this 
final 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 rule will reduce regulations that are outdated and 
otherwise clarify existing requirements. Because this final rule does 
not impose any additional regulatory burdens, we certify that this 
final 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 $165 
million, using the most current (2021) Implicit Price Deflator for the 
Gross Domestic Product. This final rule will not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    We estimate the benefits of this rule in terms of cost savings. We 
derive the cost savings to industry from the reduction in labor 
associated with the reporting, recordkeeping, performance standards, 
and third-party disclosure requirements. Similarly, 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 
$69.71 million at a 7 percent discount rate and $97.89 million at a 3 
percent discount rate. Annualized total cost savings are $6.58 million. 
We estimate the costs to read the rule for all reporting respondents. 
The present value costs are $1.60 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

[[Page 3647]]

discount rate. A summary of the quantified cost savings and costs of 
the rule are presented in Table 1.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Units
                                        Primary                                    ------------------------------------------------
             Category                  estimate      Low estimate    High estimate                   Discount rate      Period              Notes
                                                                                     Year dollars      (percent)        covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/          $6.58           $6.58           $6.58            2021               7              20  ....................
     year.                                    6.58            6.58            6.58            2021               3              20
    Annualized Quantified.........  ..............  ..............  ..............  ..............               7  ..............  ....................
                                                                                                                 3
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  ....................
Costs:
    Annualized Monetized $millions/           0.14            0.14            0.14            2021               7              20  ....................
     year.                                    0.10            0.10            0.10            2021               3              20
    Annualized Quantified.........  ..............  ..............  ..............  ..............               7  ..............  ....................
                                                                                                                 3
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  ....................
Transfers:
    Federal Annualized Monetized    ..............  ..............  ..............  ..............               7  ..............  ....................
     $millions/year.                                                                                             3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:
                                   ---------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized      ..............  ..............  ..............  ..............               7  ..............  ....................
     $millions/year.                                                                                             3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:
                                   ---------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the rule does not impose any additional 
regulatory burdens, we certify that the final rule will not have a 
significant economic impact on a substantial number of small entities. 
This analysis, as well as other sections in this document and the 
Preamble of the final rule, serves as the Final Regulatory Flexibility 
Analysis, as required under the Regulatory Flexibility Act. The full 
preliminary analysis of economic impacts is available in the docket for 
this final rule (Ref. 18) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    The Agency has 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 environmental 
impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the annual reporting, recordkeeping, and third-party 
disclosure burden. 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.
    Title: Electronic Products; OMB Control No. 0910-0025--Revision
    Description: FDA is amending 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 various reports and 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.

[[Page 3648]]



                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Number of                                                 Total
        Activity; 21 CFR section                  FDA form              Number of     responses per   Total annual       Average burden per       hours
                                                                       respondents     respondent       responses             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............
Supplemental reports--1002.11(a)-(b)     ..........................             440             2.5           1,100  0.5 (30 minutes).........       550
 \3\.
Abbreviated reports--1002.12 \3\.......  3629--General abbreviated               54             1.8              97  5........................       485
                                          report.
                                         3646--Mercury Vapor Lamp
                                          Products Radiation Safety
                                          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          3649--ARO.................              75               4             300  2........................       600
 reports--1002.20 \3\.
Exemption requests--1002.50(a) and       3642--General                            4             1.3               5  1........................         5
 1002.51 \4\.                             correspondence.
Product and sample information--1005.10  2767--Sample product......               5               1               5  0.1 (6 minutes)..........         1
 \4\.
Identification information and           2877--Imports declaration.          12,620             2.5          31,550  0.2 (12 minutes).........     6,310
 compliance status--1005.25 \4\.
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.
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 have requested 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 have not requested
  revision of this line item at this time.


                               Table 3--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\
----------------------------------------------------------------------------------------------------------------
Manufacturer test and                    1,409           1,650       2,324,850  0.12 (7 minutes)         278,982
 distribution records--
 1002.30 and 1002.31(a) \3\.
Dealer/distributor records--             2,909              50         145,450  0.05 (3 minutes)           7,273
 1002.40 and 1002.41 \3\.
Information on diagnostic x-                50               1              50  0.5 (30 minutes)              25
 ray systems--1020.30(g) \4\.

[[Page 3649]]

 
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 have requested 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 have not requested revision of this line item at this time.


                           Table 4--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                        1               1               1                 12              12
 information 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                   1,230              34          41,820   0.3 (18 minutes)          12,546
 diagnostic x-ray
 components--...............
1020.30(d), (d)(1)-(2) (Form
 FDA 2579--Assembler report)
 \4\........................
Information on diagnostic x-                6               1               6                 55             330
 ray 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                     6               1               6                200           1,200
 safety and technical
 information--1020.30(h)(1)-
 (4) \3\....................
Fluoroscopic x-ray system                   5               1               5                 25             125
 safety and technical
 information--1020.30(h)(5)-
 (6) and 1020.32(a)(1), (g),
 and (j)(4) \3\.............
CT equipment--1020.33(c)-                   5               1               5                150             750
 (d), (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                    1               1               1                 20              20
 safety instructions--
 1030.10(c)(4) \3\..........
Microwave oven safety                       1               1               1                 20              20
 information and
 instructions--1030.10(c)(5)
 (i)-(iv) \3\...............
Microwave oven warning                      1               1               1                  1               1
 labels--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                            1               1               1                 10              10
 instructions--1040.20 \3\..
Mercury vapor lamp labeling--               1               1               1                  1               1
 1040.30(c)(1)(ii) \3\......
Mercury vapor lamp                          1               1               1                  1               1
 permanently 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 have not requested revision of this line item at this time.
\4\ We have requested revision of this information collection.

    The estimates were generated from discussions with subject matter 
experts at FDA.
    FDA is revising the applicability of the recordkeeping and 
reporting requirements for some products (Sec.  1002.1). We revised the 
burden estimates for product reports, supplemental reports, abbreviated 
reports, annual reports, manufacturer test and distribution records, 
and dealer and distributor records by reducing the number of 
respondents/recordkeepers to reflect the revised applicability of the 
recordkeeping and reporting requirements. We also 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''

[[Page 3650]]

 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 amended applicability of the recordkeeping requirements for 
dealer and distributor records (see Sec. Sec.  1002.40 and 1002.41) 
results in a small decrease in the number of recordkeepers.
    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 amending the timing for submission of reporting requirements 
for AROs that are not associated with a death or serious injury (Sec.  
1002.20). The 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 amending 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 amending 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)). FDA is also withdrawing the 
language that requires 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 amending the reporting requirements for manufacturers that 
incorporate a certified laser product to reduce reporting that is 
considered duplicative under certain conditions. Manufacturers that 
incorporate a certified laser system meeting the conditions of Sec.  
1010.2(e) are considered distributors of the certified laser and only 
subject to the applicable distribution recordkeeping requirements under 
Sec. Sec.  1002.40 and 1002.41 for the certified products. Accordingly, 
we have reduced the number of respondents for ``Laser products 
information--1040.10(h)(1)(i)-(vi)'' and ``Laser product service 
information--1040.11(h)(2)(i)-(ii).''
    FDA is repealing the performance standards for ultrasonic therapy 
products (Sec.  1050.10). We have therefore removed the burden estimate 
associated with Sec.  1050.10.
    We received several comments related to the proposed rule. 
Descriptions of the comments and our responses are provided in Section 
V of this document, Comments on the Proposed Rule and FDA Response. 
Comments and responses related to the provisions that underlie the 
information collection are described in the following sections: section 
V.B, regarding general comments; section V.E, regarding records and 
reports; section V.F, regarding reports of assembly, forms and 
guidances; section V.G, regarding accidental radiation occurrences; and 
section V.H, regarding laser comments. We have not made changes to the 
estimated burden as a result of the comments.
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the PRA.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in E.O. 13132. We have determined that this 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 E.O. 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. 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

[[Page 3651]]

radiation from electronic products under certain circumstances.
    This final rule does not impose any new performance standard 
requirements. This rule prescribes a reduction in Federal standards 
(through repeal of Sec.  1050.10) pursuant to section 534 of the FD&C 
Act. This rule removes or excludes applicability of certain Federal 
standards, which no longer preempt any State issued performance 
standards to that same extent.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this final rule in accordance with the principles 
set forth in E.O. 13175. We have 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. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

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. 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.
2. NCRP, ``Radiation Dose Management for Fluoroscopically-Guided 
Interventional Procedures,'' Report No. 168, 2010, available at 
https://ncrponline.org/publications/reports/ncrp-report-168/.
*3. FDA, CDRH Health, ``Initiative to Reduce Unnecessary Radiation 
Exposure from Medical Imaging'' (2010), available at https://
www.fda.gov/radiation-emitting-products/initiative-reduce-
unnecessary-radiation-exposure-medical-imaging/white-paper-
initiative-reduce-unnecessary-radiation-exposure-medical-
imaging#:~:text=practicing%20medical%20community.-
,Initiative%20to%20Reduce%20Unnecessary%20Radiation%20Exposure%20from
%20Medical%20Imaging,CT%2C%20fluoroscopy%2C%20and%20nuclear%20medicin
e.
*4. FDA, ``Medical X-ray Imaging,'' available at https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/default.htm.
*5. 2016 TEPRSSC Meeting, October 25-26, 2016, available at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/ucm526004.htm.
6. NCRP, ``Radiation Protection in Dentistry,'' Report No. 145, 
2003, available at https://ncrponline.org/publications/reports/ncrp-reports-145/.
*7. American Dental Association and FDA, ``Dental Radiographic 
Examinations: Recommendations for Patient Selection and Limiting 
Radiation Exposure,'' revised: 2012, available at https://www.fda.gov/media/84818/download.
*8. 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.
*9. ICRP, ``The 2007 Recommendations of the International Commission 
on Radiological Protection. ICRP publication 103.'' Annals of the 
ICRP. 2007;37(2-4):1-332, available at http://www.icrp.org/publication.asp?id=ICRP%20Publication%20103.
10. Nationwide Evaluation of X-Ray Trends (NEXT), ``Tabulation and 
Graphical Summary of the 2014-2015 Dental Survey.'' February 2019. 
CRCPD Publication-E-16-2, available at https://cdn.ymaws.com/www.crcpd.org/resource/collection/81C6DB13-25B1-4118-8600-9615624818AA/E-19-2_2014-2015_Dental_NEXT_Summary_Report.pdf.
11. NCRP, ``Radiation Protection in Dentistry and Oral and 
Maxillofacial Imaging. Report No. 177,'' 2019, available at https://ncrponline.org/shop/reports/report-no-177/.
*12. OMB directive Circular A-119, ``Federal Participation in the 
Development and Use of Voluntary Consensus Standards and in 
Conformity Assessment Activities,'' available at https://www.federalregister.gov/documents/2016/01/27/2016-01606/revision-of-omb-circular-no-a-119-federal-participation-in-the-development-and-use-of-voluntary.
*13. FDA, ``Requests for Feedback and Meetings for Medical Device 
Submissions: The Q-Submission Program,'' May 7, 2019, available at 
https://www.fda.gov/media/114034/download.
14. IEC 60417:2002 DB, ``Graphical Symbols for Use on Equipment,'' 
available at https://webstore.iec.ch/publication/2098.
*15. FDA, Import Program, available at https://www.fda.gov/industry/import-program-food-and-drug-administration-fda.
*16. FDA, ``Medical X-Ray Imaging Devices Conformance with IEC 
Standards,'' May 8, 2019, available at https://www.fda.gov/media/99466/download.
17. NCRP, ``Management of Exposure to Ionizing Radiation: Radiation 
Protection Guidance for the United States. Report No. 180,'' 2018, 
available at https://ncrponline.org/shop/reports/report-no-180-management-of-exposure-to-ionizing-radiation-radiation-protection-guidance-for-the-united-states-2018-2018/.
*18. 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 Parts 1000 and 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 1030

    Electronic products, Microwave ovens, Radiation protection.

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, 21 CFR parts 
1000, 1002, 1010, 1020, 1030, and 1050 are amended as follows:

[[Page 3652]]

PART 1000--GENERAL

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

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

0
2. Amend Sec.  1000.3 by revising paragraph (a) and removing paragraph 
(s) and redesignating paragraphs (t) and (u) as paragraphs (s) and (t).
    The revision reads as follows:


Sec.  1000.3   Definitions.

* * * * *
    (a) Accidental radiation occurrence means a single accidental event 
or series of accidental events that has/have resulted in injurious or 
potentially injurious exposure of any person to electronic product 
radiation as a result of the manufacturing, testing, or use of an 
electronic product.
* * * * *

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:
* * * * *

                                         Table 1 to Sec.   1002.1--Record and Reporting Requirements by Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Manufacturer                                                                   Dealer &
----------------------------------------------------------------------------------------------------------------------------------------   distributor
                                                                                                                  Test     Distribution ----------------
                                                     Product   Supplemental    Abbreviated     Annual reports    records      records      Distribution
                     Products                        reports      reports    reports 1002.12      1002.13      1002.30(a)   1002.30(b)   records 1002.40
                                                     1002.10      1002.11                                          \1\          \2\        and 1002.41
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIAGNOSTIC X-RAY \3\ (1020.30, 1020.31, 1020.32,
 1020.33):
  Computed tomography............................  ..........  ............  ...............  ...............          X             X                X
  X-ray system \4\...............................  ..........  ............  ...............  ...............          X             X                X
  Tube housing assembly..........................  ..........  ............  ...............  ...............          X             X   ...............
  X-ray control..................................  ..........  ............  ...............  ...............          X             X                X
  X-ray high voltage generator...................  ..........  ............  ...............  ...............          X             X                X
  X-ray table or cradle..........................  ..........  ............  ...............  ...............          X             X                X
  X-ray film changer.............................  ..........  ............  ...............  ...............          X             X   ...............
  Vertical cassette holders mounted in a fixed     ..........  ............  ...............  ...............          X             X                X
   location and cassette holders with front
   panels........................................
  Beam-limiting devices..........................  ..........  ............  ...............  ...............          X             X                X
  Spot-film devices and image intensifiers         ..........  ............  ...............  ...............          X             X                X
   manufactured after April 26, 1977.............
  Cephalometric devices manufactured after         ..........  ............  ...............  ...............          X             X   ...............
   February 25, 1978.............................
  Image receptor support devices for mammographic  ..........  ............  ...............  ...............          X             X                X
   X-ray systems manufactured after September 5,
   1978..........................................
CABINET X RAY (1020.40):
  Baggage inspection.............................          X            X    ...............               X           X             X                X
  Other..........................................          X            X    ...............               X           X             X   ...............
PRODUCTS INTENDED TO PRODUCE PARTICULATE
 RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR
 CABINET X-RAY:
  Medical........................................  ..........  ............  ...............  ...............          X             X   ...............
  Analytical.....................................  ..........  ............               X                X           X             X   ...............
  Industrial.....................................  ..........  ............               X                X           X             X   ...............
TELEVISION PRODUCTS (1020.10):
  <0.1 milliroentgen per hour (mR/hr) IRLC \5\...  ..........  ............           X \8\            X \6\   ..........  ............  ...............
  >=0.1mR/hr IRLC \5\............................      X \8\   ............  ...............               X           X             X   ...............
MICROWAVE/RF:
  MW ovens (1030.10).............................      X \8\   ............  ...............               X           X             X   ...............
  MW diathermy...................................  ..........  ............               X   ...............  ..........  ............  ...............
  MW heating, drying, security systems...........  ..........  ............               X   ...............  ..........  ............  ...............
  RF sealers, electromagnetic induction and        ..........  ............               X   ...............  ..........  ............  ...............
   heating equipment, dielectric heaters (2-500
   megahertz)....................................
OPTICAL:
  Laser products (1040.10, 1040.11)..............  ..........  ............  ...............  ...............  ..........  ............  ...............
  Class I lasers and products containing such          X \8\   ............  ...............               X           X   ............  ...............
   lasers \7 9\..................................
  Class I laser products containing class IIa,             X   ............  ...............               X           X             X   ...............
   II, IIIa, lasers \7 9\........................
  Class IIa, II, IIIa lasers and products other            X   ............  ...............               X           X             X                X
   than class I products containing such lasers
   \7 9\.........................................
  Class IIIb and IV lasers and products                    X            X    ...............               X           X             X                X
   containing such lasers \7\....................
SUNLAMP PRODUCTS (1040.20):
  Lamps only.....................................          X   ............  ...............  ...............  ..........  ............  ...............
  Sunlamp products...............................          X            X    ...............               X           X             X                X
  Mercury vapor lamps (1040.30)..................  ..........  ............  ...............  ...............  ..........  ............  ...............
  R lamps and T lamps............................  ..........  ............               X   ...............  ..........  ............  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\ The requirement includes Sec.  Sec.   1002.31 and 1002.42, if applicable.
\3\ Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see Sec.   1020.30(d)(1)-(3) of this chapter.
\4\ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in Sec.   1020.30(c) of this
  chapter.
\5\ Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (Sec.   1020.10(c)(3)(iii)) of this chapter.
\6\ Annual report is for production status information only.
\7\ Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.

[[Page 3653]]

 
\8\ Manufacturers are exempt from product reports (Sec.   1002.10) and abbreviated reports (Sec.   1002.12), except the first product or abbreviated
  report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance,
  service, or failure (e.g., Class I optical disc products, laser printers).
\9\ Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified
  laser and only subject to the applicable distribution recordkeeping requirements under Sec.  Sec.   1002.40 and 1002.41 for the certified products.

Sec.  1002.13   [Amended]

0
6. Amend Sec.  1002.13 by removing paragraph (c).

0
7. 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 either electronically through 
Center for Devices and Radiological Health eSubmitter or addressed to 
the 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. The quarterly report must cover information required under 
paragraphs (b)(1) through (7) of this section for each occurrence were 
known to the manufacturer. Occurrences may be grouped to identify the 
most common circumstances and potential cause(s), including but not 
limited to, design changes, manufacturing, or user. Planned 
mitigation(s) with an assessment of effectiveness, or a justification 
for why mitigation is not necessary, must be associated with each 
occurrence or grouping of similar occurrences. 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
8. 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
9. Amend Sec.  1010.2 by adding paragraph (e) to read as follows:


Sec.  1010.2   Certification.

* * * * *
    (e) Laser products under Sec.  1040.10 of this chapter that 
incorporate a certified laser system (laser product) will be considered 
to have met the certification requirements in this section if all of 
the following conditions are met:
    (1) The incorporated laser system is not a laser product intended 
for use as a component or replacement as described in Sec.  
1040.10(a)(1) and (2) of this chapter;
    (2) The manufacturer of the incorporated laser system has certified 
such laser system under this section and meets the reporting 
requirements under part 1002 of this chapter;
    (3) The product incorporating the certified laser system is not 
independently subject to additional reporting or performance standards 
requirements;
    (4) The incorporated laser system is not modified as defined in 
Sec.  1040.10(i) of this chapter, and all performance features that 
apply to the incorporated laser system under Sec.  1040.10(f) are 
available on the product incorporating the certified laser system;
    (5) All labeling requirements that apply to the incorporated laser 
system under Sec. Sec.  1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3) 
of this chapter are visible on the outside of the product incorporating 
the certified laser system, with the exception that the certification 
or identification labels need not be visible on the outside of products 
incorporating a certified Class I laser;
    (6) The incorporated laser system is installed in accordance with 
the instructions provided by the manufacturer of the incorporated laser 
system, including instructions for placing additional externally facing 
labels found in paragraph (e)(5) of this section, and meeting the other 
conditions in paragraphs (e)(1) through (8) of this section;
    (7) The manufacturer of the product that incorporates the laser 
system provides the end user with information required under Sec.  
1040.10(h)(1) of this chapter as provided to them by the manufacturer 
of the incorporated laser system; and
    (8) The labeling requirements under part 1010 and Sec.  1040.10(g) 
of this chapter for the incorporated laser system would be met in any 
service configuration of the product incorporating the laser system or 
when the incorporated laser system is removed from the product into 
which it had been incorporated, and reproductions of such labels are 
found in the user information.

[[Page 3654]]


0
10. Amend Sec.  1010.3 by revising paragraph (a)(2)(ii) to read as 
follows:


Sec.  1010.3   Identification.

* * * * *
    (a) * * *
    (2) * * *
    (ii) The month and year of manufacture shall be provided clearly 
and legibly, without abbreviation, and with the year shown as a four-
digit number as follows in this paragraph. Alternatively, a 
manufacturer may utilize a manufacturing symbol and date format that 
conforms with an applicable FDA recognized consensus standard.

Manufactured: (Insert Month and Year of Manufacture.)

* * * * *

0
11. Amend Sec.  1010.4 by revising paragraphs (b) introductory text, 
(b)(1), and (b)(2) 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:
    (1) You must either:
    (i) Submit the variance application and supporting materials to 
CDRH by email using the [email protected] mailbox; 
or
    (ii) Submit an original copy of the variance application by mail 
to: U.S. Food and Drug Administration, Center for Devices and 
Radiological Health, Document Mail Center, Bldg. 66, Rm. G609, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002.
    (2) The application for variance shall include the following 
information:
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING 
PRODUCTS

0
12. 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
13. Amend Sec.  1020.10 by revising paragraph (a) to read as follows:


Sec.  1020.10   Television receivers with cathode ray tubes.

    (a) Applicability. The provisions of this section are applicable to 
television receivers with cathode ray tubes manufactured subsequent to 
January 15, 1970.
* * * * *

0
14. Amend Sec.  1020.30 by revising paragraphs (d)(1) and (d)(2)(ii) 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 (Form FDA 2579 made available at 
https://www.fda.gov/about-fda/reports-manuals-forms/forms) 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 responsible for radiation protection within 15 days 
following completion of the assembly.
    (2) * * *
    (ii) Certified accessory components;
* * * * *

PART 1030--PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY 
EMITTING PRODUCTS

0
15. The authority citation for part 1030 continues to read as follows:

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

0
16. Amend Sec.  1030.10 by revising paragraph (c)(6)(iv) introductory 
text as follows:


Sec.  1030.10   Microwave ovens.

* * * * *
    (c) * * *
    (6) * * *
    (iv) Upon application by a manufacturer, the Director, Center for 
Devices and radiological Health, Food and Drug Administration, may 
grant an exemption from one or more of the statements (radiation safety 
warnings) specified in paragraph (c)(6)(i) of this section. Such 
exemption shall be based upon a determination by the Director that the 
microwave oven model for which the exemption is sought should continue 
to comply with paragraphs (c)(1) through (3) of this section under the 
adverse condition of use addressed by such precautionary statement(s). 
An application shall be submitted to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Copies of the written portion of the application, 
including supporting data and information, and the Director's action on 
the application will be maintained by the Dockets Management Branch for 
public review. The application shall include:
* * * * *

PART 1050--[REMOVED AND RESERVED]

0
17. Under the authority of 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-
360ss, 371, 381, part 1050 is removed and reserved.

    Dated: January 4, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-00922 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P


