FDA Publishes 2 Q-Submission Guidances

FDA has published one final and one draft guidance on aspects of its medical device Q-Submission program. The final guidance Request for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program gives an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. It notes that the interactions can include written feedback and/or a meeting related to various potential or submitted medical device applications.

The draft guidance Electronic Submission Template for Medical Device Q-Submissions introduces those who make Q-submissions to CDRH and CBER to the current resources and associated content developed and made publicly available to support certain Q-Sub electronic submissions to FDA, specifically pre-submissions. It says it represents one of several steps in meeting the agency’s commitment to developing electronic submission templates as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.