FDA Issues Draft Guidance on QMSR Information for Premarket Submissions

The FDA has issued a draft guidance outlining the type and formatting of information manufacturers should submit to support compliance with the enhanced Quality Management System Regulation (QMSR). The guidance clarifies expectations around documented processes, risk management, supplier controls, and traceability for systems aligned with ISO 13485:2016 and the current 21 CFR Part 820 regime. Manufacturers are encouraged to begin gap-assessments and align their QMS documentation ahead of the February 2, 2026 effectiveness date of the QMSR. Read the source article here:

Keywords: FDA QMSR draft guidance, ISO 13485 alignment, 21 CFR 820, medical device quality system, risk management, supplier controls, traceability, QMSR 2026 compliance, Pulse Axis Medical Device Consulting