[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Rules and Regulations]
[Pages 18439-18444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5, 801, 803, 807, 814, 820, 821, 822, 830, 860, 884, 
900, and 1002

[Docket No. FDA-2020-N-0011]


Medical Devices; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending its medical device regulations. These revisions are necessary 
to reflect changes to the Agency's Center for Devices and Radiological 
Health's organizational structure, including the reorganization of its 
offices. The revisions replace references to the obsolete offices and 
positions with the current information, update the physical addresses 
for such offices, and correct inaccurate citations. In addition, as 
part of this effort we made other editorial non-substantive changes to 
correct other addresses, references, and citations, as appropriate. The 
rule does not impose any new regulatory requirements on affected 
parties. This action is editorial in nature and is intended to improve 
the accuracy of the Agency's regulations.

DATES: This rule is effective April 1, 2020.

FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of 
Policy, Center for Devices and Radiological Health, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5519, Silver Spring, MD 20993-0002, 301-796-5837.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Center for Devices and Radiological Health (CDRH) has 
reorganized (84 FR 22854, May 20, 2019) to create an agile 
infrastructure that can adapt to future organizational, regulatory, and 
scientific needs. The goal of this change is to implement more 
efficient, consistent work processes across CDRH that better support 
and advance CDRH's public health mission and vision. The reorganization 
will integrate CDRH's premarket and postmarket program functions along 
product lines, allowing experts to leverage their knowledge to optimize 
decision making across the product life cycle. Implementation took a 
phased approach starting on March 18, 2019, and was completed on 
September 30, 2019.
    Historically, CDRH has been organized according to the stage of the 
product's life cycle, e.g., premarket review, postmarket surveillance, 
and compliance, rather than by the type of product regulated. The 
reorganization integrates these functions by product type within the 
Office of Product Evaluation and Quality (OPEQ). OPEQ was formed by 
combining the Office of Compliance, the Office of Device Evaluation, 
the Office of Surveillance and Biometrics, and the Office of In Vitro 
Diagnostics and Radiological Health into one super office focused on a 
Total Product Lifecycle approach to medical device oversight. Within 
OPEQ, there are offices divided by product type, referred to as Offices 
of Health Technology (OHT), as well as cross-cutting offices focusing 
on specific policy and programmatic needs including the Office of 
Regulatory Programs and the Office of Clinical Evidence and Analysis. 
In addition, the reorganization established the Office of Policy, which 
includes two teams, the Guidance, Legislation and Special Projects Team 
and the Regulatory Documents and Special Projects Team, with no changes 
in the functions for CDRH Policy. The reorganization also established 
the Office of Strategic Partnerships and Technology Innovation (OST), 
which combined the Science and Strategic Partnerships, Digital Health, 
Health Informatics and Innovation teams. There are no changes in 
functions within the different OST teams. CDRH reorganization also 
realigned Management Services within the Center to ensure 
administrative functions in CDRH are optimally aligned, structured, and 
deliver excellent service. The reorganization streamlined the Center's 
communication functions, by combining the internal and external 
communication functions, including CDRH Executive Secretary and Speaker 
Liaison, into the renamed Division of Communication in the Office of 
Communication and Education, and created an Internal Communication 
Branch. The structure of the Office of Science and Engineering 
Laboratories remains unchanged.
    As part of this effort, we are also making other editorial non-
substantive changes to correct other addresses, references, and 
citations, as appropriate.

II. Description of the Technical Amendments

    The regulations specified in this rule have been revised to replace 
all references to ``Office of Device Evaluation'', ``Office of 
Compliance'', ``Office of Surveillance and Biometrics'' with ``Office 
of Product Evaluation and Quality,'' and where, appropriate, we have 
used the term ``Office,'' ``Division,'' ``Team'' or ``Office of Health 
Technology'' to reflect the responsible unit within CDRH. We have also 
made conforming edits, as appropriate. In addition, because of the 
reorganization, the physical location for many of the offices changed, 
and thus, we have made non-substantive amendments to ensure that the 
room numbers and addresses reflect the current information, and other 
changes as necessary to update outdated addresses, references, and 
citations in the regulations pertaining to medical devices. The rule 
does not impose any new regulatory requirements on affected parties. 
The amendments are editorial in nature and should not be construed as 
modifying any substantive standards or requirements.

III. Notice and Public Comment

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Section 
553 of the Administrative Procedure Act (APA) exempts ``rules of agency 
organization, procedure, or practice'' from proposed rulemaking (i.e., 
notice and comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also 
exempt when an agency finds ``good cause'' that notice and comment 
rulemaking procedures would be ``impracticable, unnecessary, or 
contrary to the public interest.'' 5 U.S.C. 553(b)(3)(B).
    FDA has determined that this rulemaking meets the notice and 
comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (B). FDA's 
revisions make technical or non-substantive changes that pertain solely 
to the CDRH reorganization and office move and do not alter any 
substantive

[[Page 18440]]

standard. FDA does not believe public comment is necessary for these 
minor revisions.
    The APA allows an effective date less than 30 days after 
publication as ``provided by the agency for good cause found and 
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective 
date is unnecessary in this case because the amendments do not impose 
any new regulatory requirements on affected parties. As a result, 
affected parties do not need time to prepare before the rule takes 
effect. Therefore, FDA finds good cause for the amendments to become 
effective on the date of publication of this action.

List of Subjects

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Parts 803 and 821

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Parts 820 and 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 830

    Administrative practice and procedure, Labeling, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

21 CFR Part 884

    Medical Devices.

21 CFR Part 900

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

21 CFR Part 1002

    Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, 21 CFR 
parts 5, 801, 803, 807, 814, 820, 821, 822, 830, 860, 884, 900, and 
1002 are amended as follows:

PART 5--ORGANIZATION

0
1. The authority citation for part 5 continues to read as follows:

    Authority:  5 U.S.C. 552; 21 U.S.C. 301-397.


0
2. In Sec.  5.1100, revise the entries for ``Center for Devices and 
Radiological Health'' through ``Office of In Vitro Diagnostics and 
Radiological Health'' to read as follows:


Sec.  5.1100   Headquarters.

* * * * *
Center for Devices and Radiological Health.\12\
---------------------------------------------------------------------------

    \12\ Mailing address: 10903 New Hampshire Ave., Bldg. 66, Silver 
Spring, MD 20993.
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Office of the Center Director.
    Quality Management Staff.
Office of Communication and Education.
    Digital Communication Media Staff.
    Program Management Operations Staff.
    Division of Communication.
    External Communications Branch.
    Web and Graphics Branch.
    Internal Communication Branch.
Division of Employee Training and Development.
    Employee Development Branch.
    Technology and Learning Management Branch.
Division of Industry and Consumer Education.
    Premarket Programs Branch.
    Postmarket and Consumer Branch.
Division of Information Disclosure.
    Freedom of Information Branch A.
    Freedom of Information Branch B.
Office of Management.
    Planning and Program Analysis Staff.
    Division of Acquisition Services.
    Advanced Acquisitions.
    Simplified Acquisitions.
    Acquisition Planning Assistance.
Division of Workforce Management.
    Recruitment.
    Human Capital Management.
    Special Programs.
Division of Management Services.
    Travel and Conference Management.
    Committee Management and Planning.
    Space and Facilities Management.
Division of Financial Management.
    Budget Formulation.
    Budget Execution.
    Financial Accountability.
Office of Policy.
    Guidance, Legislation and Special Projects.
    Regulatory Documents and Special Projects.
Office of Product Evaluation and Quality.
    Quality and Analytics Staff.
    Clinical and Scientific Policy Staff.
    Strategic Initiatives Staff.
    Regulation, Policy and Guidance Staff.
    Compliance and Quality Staff.
    Operations Staff.
Office of Regulatory Programs.
    Division of Regulatory Programs 1 (Division of Submission Support).
    Division of Regulatory Programs 2 (Division of Establishment 
Support).
    Division of Regulatory Programs 3 (Division of Market 
Intelligence).
Office of Clinical Evidence and Analysis.
    Division of Clinical Evidence and Analysis 1 (Division of Clinical 
Science and Quality).
    Division of Clinical Evidence and Analysis 2 (Division of 
Biostatistics).
Office of Health Technology 1 (OHT1: Office of Ophthalmic, Anesthesia, 
Respiratory, ENT and Dental Devices).
    Division of Health Technology 1A (Division of Ophthalmic Devices).
    Division of Health Technology 1B (Division of Dental Devices).
    Division of Health Technology 1C (Division of ENT, Sleep Disordered 
Breathing, Respiratory and Anesthesia Devices).
Office of Health Technology 2 (OHT2: Office of Cardiovascular Devices).
    Division of Health Technology 2A (Division of Cardiac 
Electrophysiology, Diagnostics, and Monitoring Devices).
    Division of Health Technology 2B (Division of Circulatory Support, 
Structural and Vascular Devices).
    Division of Health Technology 2C (Division of Coronary and 
Peripheral Interventional Devices).
Office of Health Technology 3 (OHT3: Office of Gastrorenal, ObGyn, 
General Hospital and Urology Devices).
    Division of Health Technology 3A (Division of Renal, 
Gastrointestinal, Obesity, and Transplant Devices).
    Division of Health Technology 3B (Division of Reproductive, 
Gynecology and Urology Devices).
    Division of Health Technology 3C

[[Page 18441]]

(Division of Drug Delivery and General Hospital Devices, and Human 
Factors).
Office of Health Technology 4 (OHT4: Office of Surgical and Infection 
Control Devices).
    Division of Health Technology 4A (Division of General Surgery 
Devices).
    Division of Health Technology 4B (Division of Infection Control and 
Plastic Surgery Devices).
Office of Health Technology 5 (OHT5: Office of Neurological and 
Physical Medicine Devices).
    Division of Health Technology 5A (Division of Neurological, 
Neurointerventional and Neurodiagnostic Devices).
    Division of Health Technology 5B (Division of Neuromodulation and 
Physical Medicine Devices).
Office of Health Technology 6 (OHT6: Office of Orthopedic Devices).
    Division of Health Technology 6A (Division of Joint Arthroplasty 
Devices).
    Division of Health Technology 6B (Division of Spinal Devices).
    Division of Health Technology 6C (Division of Stereotaxic, Trauma 
and Restorative, Devices).
Office of Health Technology 7 (OHT7: Office of In Vitro Diagnostics and 
Radiological Health).
    Division of Program Operations and Management.
    Division of Chemistry and Toxicology Devices.
    Chemistry Branch.
    Diabetes Branch.
    Toxicology Branch.
    Cardio-Renal Diagnostics Branch.
    Division of Molecular Genetics and Pathology.
    Molecular Pathology and Cytology Branch.
    Molecular Genetics Branch.
    Division of Immunology and Hematology Devices.
    Hematology Branch.
    Immunology and Flow-Cytometry Branch.
    Division of Microbiology Devices.
    Viral Respiratory and HPV Branch.
    General Viral and Hepatitis Branch.
    General Bacterial and Antimicrobial Susceptibility Branch.
    Bacterial Respiratory and Medical Countermeasures Branch.
    Division of Radiological Health.
    Magnetic Resonance and Electronic Products Branch.
    Diagnostic X-Ray Systems Branch.
    Nuclear Medicine and Radiation Therapy Branch.
    Mammography, Ultrasound and Imaging Software Branch.
    Division of Mammography Quality Standards.
Office of Science and Engineering Laboratories.
    Immediate Office of the Director
    Division of Applied Mechanics.
    Division of Biomedical Physics.
    Division of Biology, Chemistry and Materials Science.
    Division of Imaging, Diagnostics, and Software Reliability.
    Division of Administrative and Laboratory Support.
Office of Strategic Partnerships and Technology Innovation.
    Innovation.
    Division of All Hazards Response Science and Strategic 
Partnerships.
    Medical Device Development Tools.
    Health of Women.
    Pediatrics and Special Populations.
    All Hazards Readiness Response and Cybersecurity.
    Patient Science and Engagement.
    Partnerships to Advance Innovation and Regulatory Science.
    Science and Special Projects Incubator.
    Standards and Conformity Assessment Program.
    Division of Digital Health.
    Operational Excellence.
    Technical and Policy Leadership Strategic Partnerships and 
Initiatives 1.
    Technical and Policy Leadership Strategic Partnerships and 
Initiatives 2.
    Strategic Initiatives and Special Projects.
    Division of Technology and Data Services.
    Business and Transformation Services.
    Data Services.
    Technology Services.
* * * * *

PART 801--LABELING

0
5. The authority citation for part 801 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 
374.


0
6. In Sec.  801.55, revise paragraph (b)(2) to read as follows:


Sec.  801.55  Request for an exception from or alternative to a unique 
device identifier requirement.

* * * * *
    (b) * * *
    (2) In all other cases, by email to: GUDIDSupport@fda.hhs.gov, or 
by correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
* * * * *

0
7. In Sec.  801.57, revise paragraph (c)(2) to read as follows:


Sec.  801.57  Discontinuation of legacy FDA identification numbers 
assigned to devices.

* * * * *
    (c) * * *
    (2) No later than September 24, 2014, the labeler submits, and 
obtains FDA approval of, a request for continued use of the assigned 
labeler code. A request for continued use of an assigned labeler code 
must be submitted by email to: GUDIDSupport@fda.hhs.gov, or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
* * * * *

PART 803--MEDICAL DEVICE REPORTING

0
8. The authority citation for part 803 continues to read as follows:

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


0
9. In Sec.  803.11, revise paragraph (d) to read as follows:


Sec.  803.11  What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?

* * * * *
    (d) Form FDA 3500A is available on the internet at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.

0
10. In Sec.  803.19(b), revise the second sentence to read as follows:


Sec.  803.19  Are there exemptions, variances, or alternative forms of 
adverse event reporting requirements?

* * * * *
    (b) * * * You must submit the request to us in writing at the 
following address: MDR Exemption Requests, Medical Device Report (MDR) 
Team, Division of Regulatory Programs 3, Office of Regulatory Programs, 
Office of Product Evaluation and Quality, 10903 New Hampshire Ave., 
Bldg. 66, Rm.1523, Silver Spring, MD 20993-0002. * * *
* * * * *

0
11. In Sec.  803.21, revise paragraph (a) to read as follows:


Sec.  803.21  Where can I find the reporting codes for adverse events 
that I use with medical device reports?

    (a) The MedWatch Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with Form FDA 3500A. You may 
obtain the coding manual from FDA's website

[[Page 18442]]

at: https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes.
* * * * *

0
12. In Sec.  803.33, revise paragraph (a) to read as follows:


Sec.  803.33   If I am a user facility, what must I include when I 
submit an annual report?

    (a) You must submit to us an annual report on Form FDA 3419. You 
must submit an annual report by January 1, of each year. You may obtain 
this form on the internet at: https://www.fda.gov/media/72292/download.
* * * * *

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
13. The authority citation for part 807 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.


0
14. In Sec.  807.21, revise paragraph (b) introductory text to read as 
follows:


Sec.  807.21   How to register establishments and list devices.

* * * * *
    (b) If the information under Sec.  807.21(a) cannot be submitted 
electronically, a waiver may be requested. Waivers will be granted only 
if use of electronic means is not reasonable for the person requesting 
the waiver. To request a waiver, applicants must send a letter to the 
Imports and Registration and Listing Team, Division of Regulatory 
Programs 2, Office of Regulatory Programs, Office of Product Evaluation 
and Quality, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver 
Spring, MD 20993-0002, that includes the following information:
* * * * *

0
15. In Sec.  807.34, revise paragraph (a) to read as follows:


Sec.  807.34   Summary of requirements for owners or operators granted 
a waiver from submitting required information electronically.

    (a) For initial registration and listing, owners or operators who 
have been granted a waiver from electronic filing using the procedures 
set forth in Sec.  807.21(b) must send a letter containing all of the 
registration and listing information described in Sec. Sec.  807.22, 
807.25 (and Sec.  807.26 when such information is requested by FDA), at 
the times described in Sec.  807.22, to: The Imports and Registration 
and Listing Team, Division of Regulatory Programs 2, Office of 
Regulatory Programs, Office of Product Evaluation and Quality, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 1432, Silver Spring, MD 20993-
0002.
* * * * *

0
16. In Sec.  807.37, revise paragraph (a) to read as follows:


Sec.  807.37   Public availability of establishment registration and 
device listing information.

    (a) Establishment registration and device listing information is 
available for public inspection in accordance with section 510(f) of 
the Federal Food, Drug, and Cosmetic Act and will be posted on the FDA 
website, with the exception of the information identified in paragraph 
(b) of this section. Requests for information by persons who do not 
have access to the internet should be directed to the Imports and 
Registration and Listing Team, Division of Regulatory Programs 2, 
Office of Regulatory Programs, Office of Product Evaluation and 
Quality, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432, Silver 
Spring, MD 20993-0002. In addition, there will be available for 
inspection at each of the Food and Drug Administration district offices 
the same information for firms within the geographical area of such 
district offices. Upon request, verification of a registration number 
or location of a registered establishment will be provided.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
17. The authority citation for part 814 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.


0
18. In Sec.  814.42, revise paragraph (d)(2) to read as follows:


Sec.  814.42   Filing a PMA.

* * * * *
    (d) * * *
    (2) Request in writing within 10 working days of the date of 
receipt of the notice refusing to file the PMA, an informal conference 
with the Director of the associated Office of Health Technology to 
review FDA's decision not to file the PMA. FDA will hold the informal 
conference within 10 working days of its receipt of the request and 
will render its decision on filing within 5 working days after the 
informal conference. If, after the informal conference, FDA accepts the 
PMA for filing, the date of filing will be the date of the decision to 
accept the PMA for filing. If FDA does not reverse its decision not to 
file the PMA, the applicant may request reconsideration of the decision 
from the Director of the Office of Product Evaluation and Quality, the 
Director of the Center for Biologics Evaluation and Research, or the 
Director of the Center for Drug Evaluation and Research, as applicable. 
The Director's decision will constitute final administrative action for 
the purpose of judicial review.
* * * * *

0
19. In Sec.  814.100, revise paragraph (e)(2) to read as follows:


Sec.  814.100   Purpose and scope.

* * * * *
    (e) * * *
    (2) Submitting an HDE to the Office of Product Evaluation and 
Quality (OPEQ), Center for Devices and Radiological Health (CDRH), the 
Center for Biologics Evaluation and Research (CBER), or the Center for 
Drug Evaluation and Research (CDER), as applicable.
* * * * *

PART 820--QUALITY SYSTEM REGULATION

0
20. The authority citation for part 820 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.


0
21. In Sec.  820.1, revise paragraph (e)(1) to read as follows:


Sec.  820.1   Scope.

* * * * *
    (e) * * * (1) Any person who wishes to petition for an exemption or 
variance from any device quality system requirement is subject to the 
requirements of section 520(f)(2) of the Federal Food, Drug, and 
Cosmetic Act. Petitions for an exemption or variance shall be submitted 
according to the procedures set forth in Sec.  10.30 of this chapter, 
the FDA's administrative procedures. For guidance on how to proceed for 
a request for a variance, contact Division of Regulatory Programs 2, 
Office of Regulatory Programs, Office of Product Evaluation and 
Quality, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1438, Silver 
Spring, MD 20993-0002.
* * * * *

[[Page 18443]]

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

0
22. The authority citation for part 821 continues to read as follows:

    Authority:  21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 
374.


0
23. In Sec.  821.2, revise paragraph (b) introductory text to read as 
follows:


Sec.  821.2   Exemptions and variances.

* * * * *
    (b) A request for an exemption or variance shall be submitted in 
the form of a petition under Sec.  10.30 of this chapter and shall 
comply with the requirements set out therein, except that a response 
shall be issued in 90 days. The Director or Deputy Directors, CDRH, or 
the Director of the Office of Regulatory Program, CDRH, shall issue 
responses to requests under this section. The petition shall also 
contain the following:
* * * * *

PART 822--POSTMARKET SURVEILLANCE

0
24. The authority citation for part 822 continues to read as follows:

    Authority:  21 U.S.C. 331, 352, 360i, 360l, 371, 374.

0
25. In Sec.  822.7, revise paragraph (a)(1) to read as follows:


Sec.  822.7  What should I do if I do not agree that postmarket 
surveillance is appropriate?

    (a) * * *
    (1) Requesting a meeting with the individual who issued the order 
for postmarket surveillance;
* * * * *

0
26. In Sec.  822.22, revise paragraph (a)(1) to read as follows:


Sec.  822.22  What recourse do I have if I do not agree with your 
decision?

    (a) * * *
    (1) Requesting a meeting with the individual who issued the order 
for postmarket surveillance;
* * * * *

PART 830--UNIQUE DEVICE IDENTIFICATION

0
27. The authority citation for part 830 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 
371.
* * * * *

0
28. In Sec.  830.110, revise paragraph (a)(1) to read as follows:


Sec.  830.110  Application for accreditation as an issuing agency.

    (a) * * *(1) An applicant seeking initial FDA accreditation as an 
issuing agency shall notify FDA of its desire to be accredited by 
sending a notification by email to: GUDIDSupport@fda.hhs.gov, or by 
correspondence to: UDI Regulatory Policy Support, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002.
* * * * *

0
29. In Sec.  830.320, revise paragraphs (c)(1) and (3) to read as 
follows:


Sec.  830.320  Submission of unique device identification information.

* * * * *
    (c) * * * (1) A labeler may request a waiver from electronic 
submission of UDI data by submitting a letter addressed to the 
appropriate Center Director explaining why electronic submission is not 
technologically feasible; send the request by email to: 
udi@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy 
Support, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver 
Spring, MD 20993-0002.
* * * * *
    (3) A labeler that has a waiver from electronic submission of UDI 
data must send a letter containing all of the information required by 
Sec.  830.310, as well as any ancillary information permitted to be 
submitted under Sec.  830.340 that the labeler wishes to submit, within 
the time permitted by Sec.  830.330, addressed to: UDI Regulatory 
Policy Support, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, 
Silver Spring, MD 20993-0002.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
30. The authority citation for part 860 continues to read as follows:

    Authority:  21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.


0
31. In Sec.  860.123, revise paragraph (b)(1) to read as follows:


Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, addressed to the Food and Drug Administration, 
Center for Devices and Radiological Health, Office of Policy Staff, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5445, Silver Spring, MD 20993-
0002; for devices regulated by the Center for Biologics Evaluation and 
Research, addressed to the Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Center, 10903 New 
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for 
devices regulated by the Center for Drug Evaluation and Research, 
addressed to the Food and Drug Administration, Center for Drug 
Evaluation and Research, Central Document Control Room, 5901-B 
Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
* * * * *

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
32. The authority citation for part 884 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
33. In Sec.  884.5360, remove and reserve paragraph (c).

PART 900--MAMMOGRAPHY

0
34. The authority citation for part 900 continues to read as follows:

    Authority:  21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.


0
35. In Sec.  900.3, revise paragraph (b)(1) to read as follows:


Sec.  900.3  Application for approval as an accreditation body.

* * * * *
    (b) * * *(1) An applicant seeking initial FDA approval as an 
accreditation body shall inform the Division of Mammography Quality 
Standards, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver 
Spring, MD 20993, Attn: Program Management Branch, of its desire to be 
approved as an accreditation body and of its requested scope of 
authority.
* * * * *

0
36. In Sec.  900.15, revise paragraph (d)(3)(i) to read as follows:


Sec.  900.15  Appeals of adverse accreditation or reaccreditation 
decisions that preclude certification or recertification.

* * * * *
    (d) * * *
    (3) * * *
    (i) A facility must request reconsideration by DMQS within 60 days 
of the accreditation body's adverse

[[Page 18444]]

appeals decision, at the following address: Food and Drug 
Administration, Center for Devices and Radiological Health, Division of 
Mammography Quality Standards, Attn: Facility Accreditation Review 
Committee, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, 
MD 20993-0002.
* * * * *

0
37. In Sec.  900.18, revise paragraph (c) introductory text to read as 
follows:


Sec.  900.18  Alternative requirements for Sec.  900.12 quality 
standards.

* * * * *
    (c) Applications for approval of an alternative standard. An 
application for approval of an alternative standard or for an amendment 
or extension of the alternative standard shall be submitted in an 
original and two copies to the Food and Drug Administration, Center for 
Devices and Radiological Health, Director, Division of Mammography 
Quality Standards, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver 
Spring, MD 20993-0002. The application for approval of an alternative 
standard shall include the following information:
* * * * *

0
38. In Sec.  900.21, revise paragraph (b)(1) to read as follows:


Sec.  900.21  Application for approval as a certification agency.

* * * * *
    (b) * * * (1) An applicant seeking FDA approval as a certification 
agency shall inform the Food and Drug Administration, Center for 
Devices and Radiological Health, Director, Division of Mammography 
Quality Standards, Attn: Program Management Branch, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002, in writing, of 
its desire to be approved as a certification agency.
* * * * *

PART 1002--RECORDS AND REPORTS

0
39. 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
40. In Sec.  1002.50, revise paragraph (c)(3) to read as follows:


Sec.  1002.50  Special exemptions.

* * * * *
    (c) * * *
    (3) Such conditions as are deemed necessary to protect the public 
health and safety. Copies of exemptions shall be available upon request 
from the Food and Drug Administration, Center for Devices and 
Radiological Health, Division of Mammography Quality Standards, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002.
* * * * *

    Dated: March 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06354 Filed 4-1-20; 8:45 am]
BILLING CODE 4164-01-P


