Q-Submission and Early Payor Feedback Request Programs for Medical Devices

The guidance on Requests for Feedback on Medical Device Submissions (Pre-Submissions Program) establishes a structured process for submission and management of Pre-Submissions and supports the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors submit a request for feedback on a medical device submission, including when the preferred method of feedback is a meeting with review staff. The guidance also provides recommendations regarding how to prepare for meetings with FDA staff. These voluntary information collection requirements support a structured process with clear recommendations for sponsors who submit a pre-submission feedback request and for FDA staff and managers involved in their review, as well as expected timeframes for scheduling meetings.

The latest form for Q-Submission and Early Payor Feedback Request Programs for Medical Devices expires 2022-12-31 and can be found here.

CDRH Presubmissions

Federal Enterprise Architecture: Health - Consumer Health and Safety