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Data / Federal rules / 2024-23701

Medical Devices; Quality System Regulation Amendments; Correction

The Food and Drug Administration published this final rule in the Federal Register on October 15, 2024. It took effect on February 2, 2026.

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What the agency says

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.

Key facts

Document number
2024-23701
Type
Final rule
Action
Final rule; correction
Agency
Health and Human Services Department; Food and Drug Administration
Published
October 15, 2024
Takes effect
February 2, 2026
Dates
Effective February 2, 2026.
Docket
Docket No. FDA-2021-N-0507
Regulation ID (RIN)
0910-AH99
Code of Federal Regulations
21 CFR 820
Pages
1

The document on federalregister.gov PDF

Other documents from the Food and Drug Administration

Everything from the Food and Drug Administration · Published in October 2024

Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.