[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Rules and Regulations]
[Pages 18792-18793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807 and 814

[Docket No. FDA-2024-N-1052]


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 certain medical device regulations to update a citation for 
information collection and conform the regulatory provisions to the 
Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does not 
impose any new 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 March 15, 2024.

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

    As a part of this technical amendment, FDA is making changes to 21 
CFR parts 807 and 814 to update a citation for information collection 
and to 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 nonsubstantive and editorial in 
nature.
    On December 29, 2022, Congress enacted the Food and Drug Omnibus 
Reform Act of 2022, Title III of 131 Division FF of the Consolidated 
Appropriations Act, 2023 (FDORA) (Pub. L. 117-328), which added and 
amended various sections of the FD&C Act. Section 3308 of FDORA added 
section 515C of the FD&C Act (21 U.S.C. 360e-4). Section 515C provides 
FDA with express authority to approve or clear predetermined change 
control plans (PCCPs) for devices requiring premarket approval 
applications (PMAs) under section 515 of the FD&C Act (21 U.S.C. 360e) 
or premarket notification under section 510(k) of the FD&C Act (510(k)) 
(21 U.S.C. 360). Under section 515C manufacturers will not need to 
submit PMAs, including a supplemental application, or a new 510(k) as 
long as the change is consistent with a PCCP approved or cleared by 
FDA.

II. Description of the Technical Amendments

    We are amending 21 CFR 807.81(b) and 814.39(b) to include 
predetermined change control plans cleared or approved, respectively, 
under 515C consistent with the statutory language in section 515C of 
the FD&C Act. The regulation, 21 CFR 807.87(m), is being revised to 
make a nonsubstantive editorial change to remove the incorrect 
information collection requirement citation. 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). Section 553 of the 
APA generally exempts ``rules of agency organization, procedure, or 
practice'' from proposed rulemaking (i.e., notice and comment 
rulemaking (5 U.S.C. 553(b)(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)(B)).
    FDA has determined that this rulemaking meets the APA's notice and 
comment exemption requirements under 5 U.S.C. 553(b)(3)(B). All the 
revisions in this rule are technical or nonsubstantive changes. Some of 
these revisions update the language in certain regulations to be 
consistent with the FD&C Act. The balance of these revisions updates an 
incorrect citation for information collection. Such technical, 
nonsubstantive 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 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.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under the authority delegated to the Commissioner of Food and Drugs, 21 
CFR parts 807 and 814 are amended as follows:

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

0
1. The authority citation for part 807 is revised to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360e-
4, 360i, 360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 
271.


0
2. In Sec.  807.81, revise paragraph (b)(1) to read as follows:


Sec.  807.81  When a premarket notification submission is required.

* * * * *
    (b)(1) A premarket notification under this subpart is not required 
for a device for which:
    (i) A premarket approval application under section 515 of the act, 
or for which a petition to reclassify under

[[Page 18793]]

section 513(f)(2) of the act, is pending before the Food and Drug 
Administration, or
    (ii) There is a predetermined change control plan (PCCP) cleared 
under section 515C of the act, provided that the change is consistent 
with the PCCP.
* * * * *


Sec.  807.87  [Amended]

0
3. Amend Sec.  807.87 by removing the phrase ``(Information collection 
requirements in this section were approved by the Office of Management 
and Budget (OMB) and assigned OMB control number 0910-0281)'' that 
appears after paragraph (m).

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
4. 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
5. In Sec.  814.39, revise paragraph (b) to read as follows:


Sec.  814.39  PMA supplements.

* * * * *
    (b) An applicant may make a change in a device after FDA's approval 
of a PMA for the device without submitting a PMA supplement if the 
change does not affect the device's safety or effectiveness and the 
change is reported to FDA in post approval periodic reports required as 
a condition to approval of the device, e.g., an editorial change in 
labeling which does not affect the safety or effectiveness of the 
device, or if the change is consistent with a predetermined change 
control plan (PCCP) approved under section 515C of the act.
* * * * *

    Dated: March 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05473 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P