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USA: Medical Devices Quality Management System Regulation Technical Amendments

Updated on : 14-12-2025

USA: Medical Devices Quality Management System Regulation Technical Amendments

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) (notified as G/TBT/N/USA/1839/Add.1). 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.This rule is effective 2 February 2026.90 Federal Register (FR) 55978, 4 December 2025; Title 21 Code of Federal Regulations (CFR) Parts 801803812860862864866868872874876878880882886888890, and 892

https://www.govinfo.gov/content/pkg/FR-2025-12-04/html/2025-21955.htm

https://www.govinfo.gov/content/pkg/FR-2025-12-04/pdf/2025-21955.pdfThis final rule; technical amendments is identified by Docket Number FDA-2025-N-4635. The Docket Folder is available from Regulations.gov at https://www.regulations.gov/docket/FDA-2025-N-4635/document and provides access to primary documents. Documents are also accessible from Regulations.gov by searching the Docket Number.Previous actions notified under the symbol G/TBT/N/USA/1839 are identified by Docket Number FDA-2021-N-0507. The Docket Folder is available from Regulations.gov at https://www.regulations.gov/docket/FDA-2021-N-0507/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

Download: USA: Medical Devices Quality Management System Regulation Technical Amendments

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