Devices

Guide on Device Quality Management Submission Info

FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System (QMS) information to include in premarket submissions. The agency says the document is intended to help companies prepare and maintain a QMS and provide sufficient information for FDA to assess compliance with the Quality Management System Regulation (QMSR). It notes that insufficient detail in a submission can lead to denial of approval, as the agency must ensure that manufacturing practices conform to current GMPs and the QMSR.

The draft guidance encourages submitters to include copies of written procedures, summaries, reports, and lists related to their QMS in their submissions. Even where the QMSR does not explicitly require documentation of certain procedures, FDA considers this type of information to be standard within a QMS and recommends its inclusion. Doing so may reduce the need for FDA to request additional information and help focus preapproval inspections.

The guidance provides examples of sufficient information to demonstrate that manufacturing methods, facilities, and controls conform to the QMSR. It also encourages manufacturers to consult FDA through the Q-Submission program if they intend to meet the submission requirements in an alternative manner. FDA staff can provide feedback on areas that might raise concerns for reviewers or investigators.

The draft guidance is open for comment, and manufacturers are encouraged to review the recommendations to ensure that their QMS documentation aligns with FDA expectations for marketing submissions.

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