Requests for Feedback on Medical Device Submissions

OMB 0910-0756

OMB 0910-0756

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 Requests for Feedback on Medical Device Submissions expires 2022-12-31 and can be found here.

OMB Details

CDRH Presubmissions

Federal Enterprise Architecture: Health - Consumer Health and Safety


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