2024-05473. 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 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

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.

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

§ 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 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.

* * * * *

§ 807.87

[Amended]

3. Amend § 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

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.

5. In § 814.39, revise paragraph (b) to read as follows:

§ 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.