OMB control number
Center for Devices and Radiological Health Appeals Processes
OMB 0910-0738 · HHS/FDA.
OMB 0910-0738
This guidance document helps implement section 517A of the Federal Food, Drug, and Cosmetic Act ,which governs judicial review of certain actions pertaining to medical devices and decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees.
The latest form for Center for Devices and Radiological Health Appeals Processes expires 2029-06-30 and is listed under ICR 202508-0910-001.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0738_Supporting Statement_2025.docx | Supporting Statement A |
 CDRH Appeals Processes Guidance Document |
Other-Guidance - CDRH Appeals Process |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202508-0910-001 | Reinstatement without change of a previously approved collection | 2025-12-04 | ||
| 202208-0910-014 | Revision of a currently approved collection | 2022-08-24 | Approved without change | |
| 201907-0910-014 | Extension without change of a currently approved collection | 2019-07-24 | Approved without change | |
| 201604-0910-002 | Extension without change of a currently approved collection | 2016-04-15 | Approved without change | |
| 201303-0910-003 | New collection (Request for a new OMB Control Number) | 2013-03-20 | Approved without change |