OMB control number
Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
OMB 0910-0756 · HHS/FDA.
OMB 0910-0756
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 is listed under ICR 202505-0910-013.
Latest Forms, Documents, and Supporting Material
0910-0756_Supporting Statement A_2026.docx
Medical Device Development Tools (MDDT)All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202505-0910-013 | Revision of a currently approved collection | 2026-02-27 | ||
| 202212-0910-007 | Revision of a currently approved collection | 2022-12-29 | Approved with change | |
| 201911-0910-014 | Extension without change of a currently approved collection | 2019-11-15 | Approved without change | |
| 201610-0910-002 | Extension without change of a currently approved collection | 2016-10-20 | Approved without change | |
| 201311-0910-002 | New collection (Request for a new OMB Control Number) | 2013-11-08 | Approved without change |
OMB Details
(CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Federal Enterprise Architecture: Health - Consumer Health and Safety