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.
Document Name |
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Supporting Statement A |
Approved with change |
Revision of a currently approved collection | 2022-12-29 | |
Approved without change |
Extension without change of a currently approved collection | 2019-11-15 | |
Approved without change |
Extension without change of a currently approved collection | 2016-10-20 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2013-11-08 |
Federal Enterprise Architecture: Health - Consumer Health and Safety