Information Collection Request
Premarket Approval of Medical Devices
ICR 202211-0910-010 · OMB 0910-0231 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0231 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3674 Certificate of Compliance w/42 CFR part 11 |
Form and Instruction | New | Repair queued |
 0231 PMAs SSA REV.docx |
Supporting Statement A | Uploaded 2023-03-30 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5826 |  Premarket Approval of Medical Devices: Reporting |
Other-Agency Guidance | Modified | |
| 257032 | Certificate of Compliance w/42 CFR part 11 |
Form and Instruction | New | |
| 209459 | Premarket Approval of Medical Devices: Maintenance of Records |
Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0231 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202001-0910-010 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |