# Medical Devices; Quality Management System Regulation Technical Amendments
> **Food and Drug Administration** · Final rule; technical amendments. · Published 2025-12-04 · Effective 2026-02-02 · 90 FR 55978
## Document
- **Document number:** 2025-21955
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 55978
- **CFR reference:** 21 CFR 801
- **Publication date:** 2025-12-04
- **Effective date:** 2026-02-02
- **HHS docket:** Docket No. FDA-2025-N-4635
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/12/04/2025-21955/medical-devices-quality-management-system-regulation-technical-amendments)
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