Rule2022-06508
Medical Devices; Technical Amendments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 29, 2022
Effective
March 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 60 (Tuesday, March 29, 2022)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06508]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
</pre></body>
</html>Indexed from Federal Register on March 29, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.