Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools

This information collection helps implement industry and Food and Drug Administration (FDA) agreed-upon goals that provide for the establishment of systems and procedures intended to improve FDA’s medical device review process under the Medical Device User Fee Act (MDUFA). Consistent with MDUFA performance goal documents developed in collaboration with interested stakeholders, we continue to improve and enhance our processes for providing feedback to sponsors of medical device submissions.

The latest form for Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools expires 2029-05-31 and can be found here.

(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Federal Enterprise Architecture: Health - Consumer Health and Safety