Medical Devices; Quality Management System Regulation Technical Amendments
fda-device · Food and Drug Administration · Rule · Published 2025-12-04 · Effective 2026-02-02 · 90 FR 55978
Document
Document number
2025-21955
Federal Register citation
90 FR 55978
CFR reference
21 CFR 801
Type
Rule
Action
Final rule; technical amendments.
Category
fda-device
Sub-agency
Food and Drug Administration
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.