Rule2024-05473
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 15, 2024
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 52 (Friday, March 15, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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