Home / Agencies / HHS / 2025-21955
Final Rule

Medical Devices; Quality Management System Regulation Technical Amendments

Agency
HHS
Document Number
2025-21955
Published
December 4, 2025
Effective Date
February 2, 2026

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.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2025-21955 Federal Register document?
Document 2025-21955 is a Final Rule published by the Department of Health and Human Services in the Federal Register on December 4, 2025, with an effective date of February 2, 2026. 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. View the original at https://www.federalregister.gov/documents/2025/12/04/2025-21955/medical-devices-quality-management-system-regulation-technical-amendments.
Is document 2025-21955 an economically significant rule?
No. Document 2025-21955 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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