Since February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) has replaced most of the former Quality System Regulation under 21 CFR Part 820. The QMSR incorporates ISO 13485:2016 by reference, aligning U.S. requirements with the international standard.
What changed
- ISO 13485:2016 is now the core of the U.S. quality system requirements for device manufacturers
- FDA retained a small number of additional requirements, for example around complaint records, labeling and packaging controls, and unique device identification
- Records such as management reviews, internal audits and supplier audits, which were previously shielded from routine FDA inspection, can now be reviewed
- Terminology now follows ISO 13485, for example the medical device file
What did not change
- FDA still inspects manufacturers itself; an ISO 13485 certificate does not replace an FDA inspection
- Premarket requirements such as 510(k), De Novo and PMA are unchanged
- Medical device reporting, corrections and removals, and UDI rules still apply
What it means for your business
For companies selling in both the U.S. and Europe, one ISO 13485 system can now support both markets, reducing duplicated procedures and audits. Companies that were built around the old QSR should review their procedures for gaps, especially management review, risk-based supplier controls and documentation structure.
MDSAP
The Medical Device Single Audit Program lets one audit satisfy the requirements of regulators in the United States, Canada, Brazil, Japan and Australia. It is built on ISO 13485 and is mandatory for selling devices in Canada.
ISO 13485 guide
Overview · Understanding the Standard · Design and Development Controls · Risk Management (ISO 14971) · CAPA, Complaints and Feedback · Suppliers and Outsourcing · Software, Cybersecurity and AI · The Certification Roadmap · ISO 13485 and the FDA QMSR
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.