Document ID: FDA-2021-N-0246-0003
Agency: fda
Document Type: Rule
Title: Medical Devices; Technical Amendments
Posted Date: 2023-03-21T04:00Z

[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 [www.gpo.gov]
[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 [email protected]. 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