Quality Management System Information for Certain Premarket Submission Reviews Draft Guidance for Industry and Food and Drug Administration Staff October 2025

GUIDANCE DOCUMENT

• Docket Number: FDA-2025-D-4051
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

The FDA is posting this document to provide advance notice to the public. After the lapse in appropriations ends, a notice of availability for the guidance will be published in the Federal Register, which will detail how to submit comments on this document.

The Food and Drug Administration (FDA or agency) is issuing this draft guidance to provide guidance to industry and FDA staff about the expectations for quality management system regulation (QMSR) requirements for premarket submissions once the final rule amending 21 CFR part 820 goes into effect. The medical device current good manufacturing practice (CGMP) requirements of the QMSR have been updated to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems (ISO 13485:2016). When final, this guidance is intended to assist medical device manufacturers in preparing and maintaining the Quality Management System (QMS) and other information required in premarket submissions stemming from the QMSR.

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All written comments should be identified with this document's docket number: FDA-2025-D-4051.