FDA drafts an ISO 13485-shaped quality system section for PMA and HDE submissions

MedDevice Startups Staff · Oct 27 · 2 min read · Via FDA draft guidance page

FDA released the draft on October 27, 2025, its first premarket guidance written for the Quality Management System Regulation. The Federal Register notice followed on November 17, after the shutdown ended, with comments due January 16, 2026. When final, it replaces the 2003 guidance Quality System Information for Certain Premarket Application Reviews, which had gone more than twenty years without a rewrite.

The draft organizes the quality system section of a PMA or HDE around the ISO 13485:2016 structure: management responsibility, resource management, product realization, and measurement, analysis and improvement. It asks for a summary of the risk-based approaches used to control QMS processes. It also wants a sampling of UDIs with their GUDID records, plus information on traceability, records control, labeling and reporting. FDA notes the FD&C Act requires it to deny approval when quality system information is inadequate, and from February 2, 2026 preapproval inspections run against the QMSR.

Most startups will not file a PMA this year. The draft still matters as the closest thing to a checklist of how FDA reads a quality system under the new rule. A 510(k) or De Novo carries no quality system section, but the inspection that follows a clearance covers the same ground. Mapping procedures to ISO clauses now avoids a second rewrite later.

Questions & Answers

What is FDA's draft guidance Quality Management System Information for Certain Premarket Submission Reviews?

It is a draft guidance FDA issued October 27, 2025 under Docket FDA-2025-D-4051 describing the quality management system information to include in PMA and HDE submissions, organized around ISO 13485:2016 as incorporated by the QMSR. It will replace a 2003 guidance.

Which submissions does the FDA QMSR premarket draft guidance apply to?

It applies to premarket approval applications and humanitarian device exemption applications, which carry a quality system section FDA reviews alongside preapproval inspections. It does not add a quality system section to 510(k)s or De Novo requests.

When were comments due on FDA docket FDA-2025-D-4051?

Comments were due January 16, 2026, following the Federal Register notice published November 17, 2025.

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