Rule2023-05657
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 21, 2023
Effective
March 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update mailing address and docket number and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature to correct errors and to ensure accuracy and clarity in the Agency's regulations.
Full Text
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<title>Federal Register, Volume 88 Issue 54 (Tuesday, March 21, 2023)</title>
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[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Rules and Regulations]
[Pages 16878-16880]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05657]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 10, 803, 812, and 822
[Docket No. FDA-2021-N-0246]
Medical Devices; Technical Amendments
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending certain medical device regulations to update mailing address
and docket number and conform the regulatory provisions to the Federal
Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any
new regulatory requirements on affected parties. This action is
editorial in nature to correct errors and to ensure accuracy and
clarity in the Agency's regulations.
DATES: This rule is effective March 21, 2023.
FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Office of
Policy, Center for Devices and
[[Page 16879]]
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5519,
Silver Spring, MD 20993-0002, 301-796-5837.
SUPPLEMENTARY INFORMATION:
I. Background
As a part of this technical amendment, the FDA Center for Devices
and Radiological Health (CDRH) is making changes to 21 CFR parts 10,
803, 812, and 822 to revise contact addresses, correct docket numbers,
and conform the regulatory provisions to the FD&C Act to ensure
accuracy and clarity in the Agency's medical device regulations. The
changes published in this notice are non-substantive and editorial in
nature.
II. Description of the Technical Amendments
The regulation, 21 CFR 10.80(h), is being revised to make a non-
substantive editorial change to update a citation that was moved from
title 42 to title 21. In Sec. 803.19(b), we are removing the address
and replacing it with a website link. We are correcting the docket
number in the regulations Sec. Sec. 812.38 and 812.47 with the docket
number specified in the codified of this rulemaking. For Sec. Sec.
822.1 and 822.4, we are adding the criterion from section
522(a)(1)(A)(ii) of the FD&C Act (21 U.S.C. 360l(a)(1)(A)(ii)) to these
provisions for consistency with the statutory language. Similarly, we
are amending Sec. 822.24 for consistency with section 522(b)(1) of the
FD&C Act. We are amending Sec. 822.7(a)(1) by removing the name of an
office that is now obsolete due to CDRH's reorganization. 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) (5 U.S.C. 553). 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 therefore 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. The revisions in this rule make
technical or non-substantive changes. Some of these revisions pertain
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 updates the omitted language from the statute or the citation
and docket number. Such technical, non-substantive changes are ``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 these amendments.
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
21 CFR Part 10
Administrative practice and procedure, News media.
21 CFR Part 803
Imports, Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 822
Medical devices, 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 10, 803, 812, and 822 are amended as follows:
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
0
1. The authority citations for part 10 continues to read as follows:
Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
0
2. In Sec. 10.80:
0
a. Remove the headings from paragraphs (b) and (d); and
0
b. Revise paragraph (h).
The revision reads as follows:
Sec. 10.80 Dissemination of draft Federal Register notices and
regulations.
* * * * *
(h) In accordance with section 534 of the Federal Food, Drug, and
Cosmetic Act, the Commissioner shall consult with interested persons
and with the Technical Electronic Product Radiation Safety Standards
Committee (TEPRSSC) before prescribing any performance standard for an
electronic product. Accordingly, the Commissioner shall publish in the
Federal Register an announcement when a proposed or final performance
standard, including any amendment, is being considered for an
electronic product, and any draft of any proposed or final standard
will be furnished to an interested person upon request and may be
discussed in detail.
* * * * *
PART 803--MEDICAL DEVICE REPORTING
0
3. The authority citation for part 803 continues to read as follows:
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
0
4. In Sec. 803.19, revise paragraph (b) to read as follows:
Sec. 803.19 Are there exemptions, variances, or alternative forms of
adverse event reporting requirements?
* * * * *
(b) If you are a manufacturer, importer, or user facility, you may
request an exemption or variance from any or all of the reporting
requirements in this part, including the requirements of Sec. 803.12.
You must submit the request to the Center for Devices and Radiological
Health (CDRH) in writing at <a href="/cdn-cgi/l/email-protection#aee3eafcfec1c2c7cdd7eec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="216c6573714e4d484258614745400f4949520f464e57">[email protected]</span></a>. Your request must
include information necessary to identify you and the device; a
complete statement of the request for exemption, variance, or
alternative reporting; and an explanation why your request is
justified. If you are requesting an exemption from the requirement to
submit reports to FDA in electronic format under Sec. 803.12(a), your
request should indicate for how long you will require this exemption.
* * * * *
[[Page 16880]]
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
5. The authority citation for part 812 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42
U.S.C. 216, 241, 262, 263b-263n.
0
6. In Sec. 812.38, revise paragraph (b)(4) to read as follows:
Sec. 812.38 Confidentiality of data and information.
* * * * *
(b) * * *
(4) Notwithstanding paragraph (b)(2) of this section, FDA will make
available to the public, upon request, the information in the IDE that
was required to be filed in Docket Number FDA-1995-S-0036 in the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, for investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. Persons wishing to request this information shall submit a
request under the Freedom of Information Act.
* * * * *
0
7. In Sec. 812.47, revise paragraph (a) to read as follows:
Sec. 812.47 Emergency research under Sec. 50.24 of this chapter.
(a) The sponsor shall monitor the progress of all investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. When the sponsor receives from the IRB information concerning
the public disclosures under Sec. 50.24(a)(7)(ii) and (iii) of this
chapter, the sponsor shall promptly submit to the IDE file and to
Docket Number FDA-1995-S-0036 in the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, copies of the information that was disclosed,
identified by the IDE number.
* * * * *
PART 822--POSTMARKET SURVEILLANCE
0
8. The authority citation for part 822 continues to read as follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
0
9. In Sec. 822.1, revise the introductory text and paragraphs (b) and
(c) and add paragraph (d) to read as follows:
Sec. 822.1 What does this part cover?
This part implements section 522 of the Federal Food, Drug, and
Cosmetic Act by providing procedures and requirements for postmarket
surveillance of class II and class III devices that meet any of the
following criteria:
* * * * *
(b) The device is intended to be implanted in the human body for
more than 1 year;
(c) The device is intended to be used outside a user facility to
support or sustain life. If you fail to comply with requirements that
we order under section 522 of the Federal Food, Drug, and Cosmetic Act
and this part, your device is considered misbranded under section
502(t)(3) of the Federal Food, Drug, and Cosmetic Act and you are in
violation of section 301(q)(1)(C) of the Federal Food, Drug, and
Cosmetic Act; or
(d) The device is expected to have significant use in pediatric
populations.
0
10. In Sec. 822.4, revise the introductory text and paragraphs (b) and
(c) and add paragraph (d) to read as follows:
Sec. 822.4 Does this part apply to me?
If we have ordered you to conduct postmarket surveillance of a
medical device under section 522 of the Federal Food, Drug, and
Cosmetic Act, this part applies to you. We have the authority to order
postmarket surveillance of any class II or class III medical device,
including a device reviewed under the licensing provisions of section
351 of the Public Health Service Act, that meets any of the following
criteria:
* * * * *
(b) The device is intended to be implanted in the human body for
more than 1 year;
(c) The device is intended to be used to support or sustain life
and to be used outside a user facility; or
(d) The device is expected to have significant use in pediatric
populations.
0
11. 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 Director of the Office that
issued the order for postmarket surveillance;
* * * * *
0
12. Revise Sec. 822.24 to read as follows:
Sec. 822.24 What are my responsibilities once I am notified that I am
required to conduct postmarket surveillance?
You must submit your plan to conduct postmarket surveillance to us
within 30 days from receipt of the order (letter) notifying you that
you are required to conduct postmarket surveillance of a device. The
manufacturer shall commence surveillance not later than 15 months after
the day the order was issued.
Dated: March 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05657 Filed 3-20-23; 8:45 am]
BILLING CODE 4164-01-P
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