U.S. FDA October 2025, released a draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews”. This document provides detailed instructions for medical device manufacturers and FDA staff on preparing and submitting Quality Management System (QMS) information as part of Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) applications.The guidance is designed to align U.S. QMS expectations with international standards particularly ISO 13485:2016 by integrating these into the new Quality Management System Regulation (QMSR). Once finalized, it will replace the 2003 guidance of the same title and will become effective from February 2, 2026
Caution : Please note that the FDA’s draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews” (October 2025) is intended for comment purposes only and is not for implementation at this stage.
WHY QMS DOCUMENTATION MATTERS IN PREMARKET APPROVAL AND HUMANITARIAN DEVICE EXEMPTION REVIEWS
FDA evaluates Quality Management System (QMS) documentation as a core element of its review during Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) submissions. This evaluation helps determine whether manufacturers have implemented adequate quality controls in compliance with the Quality Management System Regulation (QMSR).
If a manufacturer fails to show that their manufacturing methods, facilities, and controls conform to the QMSR requirements, FDA is obligated by law to deny the application.To prevent delays, manufacturers are encouraged to submit comprehensive documentation including quality procedures, summaries, and supporting reports that provide a “full description” of the QMS in sufficient detail for FDA to assess compliance.
WHAT’S NEW IN THIS FDA QMS DRAFT GUIDANCE
Here are the key updates and proposed changes:
Alignment with ISO 13485:2016
- The guidance officially supports incorporation by reference of ISO 13485:2016 and ISO 9000:2015 into 21 CFR Part 820, now termed the QMSR
- This harmonization reduces duplicative efforts for global manufacturers and strengthens international regulatory alignment.
- UDI Requirements (21 CFR 820.10 & 830)
Manufacturers must assign a UDI to devices and ensure the system complies with FDA’s UDI regulations. - Medical Device Reporting (MDR, 21 CFR Part 803)
Manufacturers must establish procedures for identifying and reporting adverse events related to their devices. - Corrections and Removals (21 CFR Part 806)
Protocols must be followed for recalls, corrections, and removals of devices that pose risks. - Recordkeeping and Labeling Controls (21 CFR 820.35 & 820.45)
Manufacturers need to maintain device history records, labeling controls, and ensure traceability of devices.
This guidance ensures manufacturers adhere to both ISO 13485:2016 and FDA-specific rules for premarket submissions.
WHAT SHOULD MANUFACTURERS DO NOW?
With the QMSR enforcement date set for February 2, 2026, manufacturers are encouraged to act early:
- Conduct a gap assessment between current QS compliance and ISO 13485:2016
- Update QMS documentation to meet the new expectations
- Train internal teams on ISO requirements and FDA reporting obligations
- Coordinate with suppliers on documentation, validation, and traceability
- Engage with FDA via the Q-Submission program for feedback on alternative approaches
GREATER INSPECTION READINESS
- FDA inspections after Feb 2, 2026 will evaluate compliance to QMSR, not the old QS regulation.
- Submitters are encouraged to complete process validations early and provide sample validation reports with the submission.
SUMMARY OF THE GUIDANCE
FDA invites comments on the draft guidance until 60 days after its Federal Register publication. For manufacturers, this is a critical window to prepare for compliance and shape the final version of the rule.