Quality Management System Information for Certain Premarket Submission Reviews

19th November 2025

Quality Management System Information for Certain Premarket Submission Reviews

The FDA’s draft guidance (October 2025) clarifies what manufacturers must include about their QMS when submitting a Premarket Approval (PMA) or Humanitarian Device Exemption (HDE). Some key points:

• The guidance aligns with the upcoming Quality Management System Regulation (QMSR) (effective 2nd February 2026) which updates 21 CFR Part 820 to incorporate by reference the international standard ISO 13485:2016. 

• Manufacturers are expected to provide a full description of manufacturing methods, facilities, and controls so FDA can assess conformity with the QMSR. 

• There is a strengthened emphasis on risk-based decision making, supplier audits, traceability, design control, ongoing monitoring of QMS performance, and internal audit results. 

• Even though this is draft guidance and not yet for implementation, organisations preparing submissions should act now to align their QMS documentation accordingly. 

Link: Quality Management System Information for Certain Premarket Submission Reviews – FDA

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