Data / Federal rules / 2025-21955
Medical Devices; Quality Management System Regulation Technical Amendments
The Food and Drug Administration published this final rule in the Federal Register on December 4, 2025. It took effect on February 2, 2026.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule "Medical Devices; Quality System Regulation Amendments" (QMSR Final Rule). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's regulations.
Key facts
- Document number
- 2025-21955
- Type
- Final rule
- Action
- Final rule; technical amendments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- December 4, 2025
- Takes effect
- February 2, 2026
- Dates
- This rule is effective February 2, 2026.
- Docket
- Docket No. FDA-2025-N-4635
- Code of Federal Regulations
- 21 CFR 801; 21 CFR 803; 21 CFR 812; 21 CFR 860; 21 CFR 862; 21 CFR 864; 21 CFR 866; 21 CFR 868; 21 CFR 872; 21 CFR 874; 21 CFR 876; 21 CFR 878; 21 CFR 880; 21 CFR 882; 21 CFR 886; 21 CFR 888; 21 CFR 890; 21 CFR 892
- Topics
- Administrative practice and procedure; Biologics; Blood; Health records; Imports; Labeling; Laboratories; Medical devices; Medical research; Ophthalmic goods and services; Packaging and containers; Radiation protection; Reporting and recordkeeping requirements; X-rays
- Pages
- 19
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on biologics · Rules on blood · Published in December 2025
Read from the Federal Register API, last updated 2026-10-23. 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.