Aug 27, 2025 · The FDA amended the title of the Quality System Regulation, and established requirements that clarify certain expectations and concepts used in ISO 13485:2016.

(1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520 (f) (2) of the Federal Food, Drug, and …

LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES …

The FDA is updating 21 CFR Part 820 with a new approach, Quality Management System Regulation (QMSR) in February 2026. This transition is a significant update to medical device quality …

The agency adopted ISO 13485 to form the core of the new QMSR. The new regulation aims to align with the international standard and supports the FDA’s objective of promoting international regulatory …

Jan 31, 2024 · The FDA has identified in the QS regulation the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements.

Aug 26, 2025 · Learn about the new FDA Quality Management System Regulation (QMSR), replacing the QSR (21 CFR Part 820) by 2026. Key changes, timeline and compliance tips.

Context: QMSR Creation On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 …

Feb 2, 2024 · The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System …

Apr 22, 2024 · The new regulation, referred to as the Quality Management System Regulation, or QMSR for short, is the medical device industry’s latest significant regulatory change and move towards more …