Health and Human Services Department Docket FDA-2021-N-0507 Final Rule

2024-23701: Medical Devices; Quality System Regulation Amendments; Correction

Get alerted when the next rule lands

New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.

Alert me on new Health and Human Services Department rules or alert me on a subject

Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.

Create a free account & build one →

Summary

The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations.

The agency’s own summary, as published.

The rule, in full

433 words as published, October 15, 2024. View the original →

Federal Register, Volume 89 Issue 199 (Tuesday, October 15, 2024) [Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)] [Rules and Regulations] [Page 82945] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2024-23701] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 820 [Docket No. FDA-2021-N-0507] RIN 0910-AH99 Medical Devices; Quality System Regulation Amendments; Correction

Agency

Food and Drug Administration, HHS.

Action

Final rule; correction. -----------------------------------------------------------------------

Summary

The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations.

Dates

Effective February 2, 2026.

For Further Information Contact

Laurie Sternberg, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5517, Silver Spring, MD 20993-0002, 240- 402-0425.

Supplementary Information

In the Federal Register of February 2, 2024 (89 FR 7496), FDA published a final rule that amended the device CGMPs requirements in 21 CFR part 820. The preamble indicated that the definition for ``batch'' or ``lot'' was set forth at Sec. 820.3 (21 CFR 820.3) but the definition for ``batch'' or ``lot'' was inadvertently omitted from the codified portion of Sec. 820.3 in the final rule. FDA is, therefore, correcting the codified for Sec. 820.3 to include the definition of ``batch'' or ``lot'' as was intended and to be consistent with the preamble of the final rule. In FR Doc. 2024-01709 appearing on page 7524 in the Federal Register of Friday, February 2, 2024 (89 FR 7496), the following correction is made: Sec. 820.3 [Corrected] 0

1. On page 7524, in amendment number 4, in the first column, in

paragraph (a) of Sec. 820.3, the definition for ``Batch or lot'' is added in alphabetical order to read as follows: ``Batch or lot means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.'' Dated: October 7, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024-23701 Filed 10-11-24; 8:45 am] BILLING CODE 4164-01-P

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

Don't miss the comment window

One Click Politics alerts you on every deadline, hearing, and rule change.

See all rules with comments due soon →