Document ID: FDA-2021-N-0246-0002
Agency: fda
Document Type: Rule
Title: Medical Devices: Technical Amendments
Posted Date: 2022-03-29T04:00Z

[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Rules and Regulations]
[Pages 17949-17950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06508]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 822

[Docket No. FDA-2021-N-0246]

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 to update mailing address 
information and to reduce (from three to one) the number of copies of 
certain documents that need to be submitted to FDA. 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, and to remove a submission requirement that is no 
longer necessary.

DATES: This rule is effective March 29, 2022.

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 to create an agile infrastructure that can adapt to future 
organizational, regulatory, and scientific needs (84 FR 22854, May 20, 
2019; 85 FR 18439, April 2, 2020). The newly formed Office of Product 
Evaluation and Quality (OPEQ) combined the former Office of Compliance, 
the Office of Device Evaluation, the Office of Surveillance and 
Biometrics, and the Office of In Vitro Diagnostics and Radiological 
Health, with a focus on a Total Product Lifecycle (TPLC) approach to 
medical device oversight. Within OPEQ there are Offices of Health 
Technology that focus on the TPLC review of specific types of medical 
devices 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. As part of this technical 
amendment, we are making a change to correctly identify the address for 
obtaining particular information. We are also amending the requirement 
for the submission of multiple copies of certain documents to a single 
copy, as FDA's receipt of multiple copies is no longer necessary. The 
changes published in this notice are non-substantive and editorial in 
nature.

II. Description of the Technical Amendments

    One regulation specified in this notice is being revised to make a 
non-substantive editorial change to update particular mailing address 
information. For the other two regulations specified in this notice, we 
are removing the requirements for submission of multiple copies of 
certain postmarket surveillance-related documents, to instead require 
submission of only one copy, because the requirement for multiple 
copies is no longer necessary. 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 under the 
Administrative Procedure Act (APA). The APA generally exempts ``rules 
of agency organization, procedure, or practice'' from the requirements 
of notice and comment rulemaking. (5 U.S.C. 553(b)(A)). Rules are also 
generally exempt from such requirements when an Agency ``for good cause 
finds (and incorporates the finding and a brief statement of reasons 
therefor in the rules issued) that notice and public procedure thereon 
are impracticable, unnecessary, or contrary to the public interest'' (5 
U.S.C. 553(b)(B)).
    FDA has determined that this rulemaking meets the APA's notice and 
comment exemption requirements. All the revisions FDA publishes through 
this notice make technical or non-substantive changes. Some of these 
revisions pertain solely to the CDRH reorganization, and constitute 
``rules of agency organization, procedure, or practice'' not subject to 
the requirements of notice and comment under 5 U.S.C. 553(b)(A). The 
balance of these revisions reduces (from three to one) the number of 
copies of certain documents that need to be submitted to FDA. Such 
technical, non-substantive change is ``a routine determination, 
insignificant in nature and impact, and inconsequential to the industry 
and to the public.'' (Mack Trucks, Inc. v. EPA, 682 F.3d 87, 94 (D.C. 
Cir. 2012)) (quotation marks and citation omitted). FDA accordingly for 
good cause finds that notice and public procedure thereon are 
unnecessary for this reduction in the number of copies of certain 
documents that must be submitted.
    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)). An effective date 30 or 
more days from the date of publication is unnecessary in this case 
because the amendments do not impose any new regulatory requirements on 
affected parties, and affected parties do not need time to ``adjust to 
the new regulation'' before the rule takes effect (Am. Federation of 
Government Emp., AFL-CIO v. Block, 655 F.2d 1153, 1156 (D.C. Cir. 
1981)). Therefore, FDA finds good cause for the amendments to become 
effective on the date of publication of this action.

List of Subjects in 21 CFR Part 822

    Medical devices, Reporting and recordkeeping requirements.

[[Page 17950]]

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under the authority delegated to the Commissioner of Food and Drugs, 21 
CFR part 822 is amended as follows:

PART 822--POSTMARKET SURVEILLANCE

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

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

0
2. Revise Sec.  822.8 to read as follows:

Sec.  822.8  When, where, and how must I submit my postmarket 
surveillance plan?

    You must submit your plan to conduct postmarket surveillance within 
30 days of the date you receive the postmarket surveillance order. For 
devices regulated by the Center for Biologics Evaluation and Research, 
send your submission 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, send 
your submission to the Central Document Room, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B, 
Ammendale Rd., Beltsville, MD 20705-1266. For devices regulated by the 
Center for Devices and Radiological Health, send your submission to the 
Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, Rm. G609, 
Silver Spring, MD 20993-0002. When we receive your original submission, 
we will send you an acknowledgment letter identifying the unique 
document number assigned to your submission. You must use this number 
in any correspondence related to this submission.

0
3. Amend Sec.  822.12 by revising the first sentence to read as 
follows:

Sec.  822.12  Do you have any information that will help me prepare my 
submission or design my postmarket surveillance plan?

    Guidance documents that discuss our current thinking on preparing a 
postmarket surveillance submission and designing a postmarket 
surveillance plan are available on the Center for Devices and 
Radiological Health's website, the Food and Drug Administration main 
website, and from the Food and Drug Administration, Center for Devices 
and Radiological Health, Office of Policy, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. * * *

0
4. Revise Sec.  822.21 to read as follows:

Sec.  822.21  What must I do if I want to make changes to my postmarket 
surveillance plan after you have approved it?

    You must receive our approval in writing before making changes in 
your plan that will affect the nature or validity of the data collected 
in accordance with the plan. To obtain our approval, you must submit 
the request to make the proposed change and revised postmarket 
surveillance plan to the applicable address listed in Sec.  822.8. You 
may reference information already submitted in accordance with Sec.  
822.14. In your cover letter, you must identify your submission as a 
supplement and cite the unique document number that we assigned in our 
acknowledgment letter for your original submission, specifically 
identify the changes to the plan, and identify the reasons and 
justification for making the changes. You must report changes in your 
plan that will not affect the nature or validity of the data collected 
in accordance with the plan in the next interim report required by your 
approval order.

    Dated: March 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06508 Filed 3-28-22; 8:45 am]
BILLING CODE 4164-01-P