Information Collection Request
Q-Submission and Early Payor Feedback Request Programs for Medical Devices
ICR 202212-0910-007 · OMB 0910-0756 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0756 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 0756 CDRH Q-Sub and Early Payor Feedback Programs REV SSA 2023.docx |
Supporting Statement A | Uploaded 2022-12-28 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 257633 |  Early Payor Feedback Program (EPFP) |
Other-Agency Template | New | |
| 209237 | (CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup |
Other-Agency Template | Modified | |
| 209236 | (CDRH/CBER) Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program |
Other-Presubmissions Guidance | Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0756 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 201911-0910-014 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |