On 31 January 2024, the U.S. Food and Drug Administration (FDA) issued a final rule amending the previous Quality Systems (QS) regulation and its Current Good Manufacturing Practice (CGMP) requirements applicable to medical devices.
The rule entered into force on 2 February 2026, formally introducing relevant amendments to part 820 of Title 21 of the Code of Federal Regulations (21 CFR 820), now referred to as the Quality Management System Regulation (QMSR).
The implementation of the QMSR represents a landmark update to U.S. medical devices’ CGMP requirements. It reflects the FDA’s intention to align its quality system expectations with internationally recognised regulatory practice.
Scope of the QMSR amendments
The entry into force of the QMSR primarily incorporates by reference the international quality management system standard ISO 13485:2016, which establishes requirements specific to medical devices.
The rule established additional provisions to 21 CFR 820, clarifying relevant specifications of ISO 13485 and including supplementary requirements that manufacturers must follow to ensure compliance. These provisions address the following key areas:
- Requirements for a QMS system – covering the entire product lifecycle, from design and development to servicing and reporting obligations
- Control of records
- Device labelling and packaging controls
- Adoption of fundamental terms and definitions – through the incorporation of Clause 3 of ISO 9000:2015
The FDA has also updated its inspection processes to support enforcement of the new framework:
- The previous Quality System Inspection Technique (QSIT) and related documentation have been withdrawn
- The Inspection of Medical Device Manufacturers Compliance Program (7382.850) now applies
With the revision of 21 CFR 820, ISO 13485 becomes the foundational framework for device CGMP requirements in the U.S.
Although the former QS regulation was deemed to be substantially similar to ISO 13485, the new rule strengthens the harmonisation and modernisation of U.S. requirements with internationally recognised expectations. As a result, medical devices under FDA jurisdiction will align more closely with global QMS expectations – including enhanced emphasis on risk-based processes and lifecycle quality management.
What the QMSR means for industry stakeholders:
Manufacturers of finished medical devices intended for commercial distribution in the U.S. must now ensure that their quality management system complies with the QMSR.
This transition will benefit manufacturers operating in multiple jurisdictions by ensuring consistency in production and control strategies, while reducing unnecessary duplication of compliance efforts.
Obelis U.S., as appointed U.S. Agent, supports manufacturers in drafting and updating compliant and inspection-ready QMS documentation.
Giorgia Peotta
Regulatory Intelligence and Innovation Department
13/02/2026
References:
FDA, Department of Health and Human Services Food and Drug Administration. (2024). Medical Devices; Quality System Regulation Amendments. Retrieved on 13/02/2026.
eCFR. (2026). Title 21, Chapter I, Subchapter H, Part 820 – Quality Management System Regulation. Retrieved on 13/02/2026.
FDA. (2026). Quality Management System Regulation (QMSR). Retrieved on 13/02/2026.
FDA. (2026). Quality Management System Regulation – Frequently Asked Questions. Retrieved on 13/02/2026.
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