Information Collection Request
Investigational Device Exemptions
ICR 202210-0910-013 · OMB 0910-0078 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0078 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 0078 IDEs SSA 2022 Rev.docx |
Supporting Statement A | Uploaded 2022-11-20 | Missing upstream |
| 0078 Change Request to include 0741 MAY 2021.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2021-05-24 | Repair queued |
 0078--change request--moving OUS to 0078--05-06-21.pdf |
Justification for No Material/Nonsubstantive Change | Uploaded 2021-05-14 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5718 |  IDE Reporting (including reports for nonsignificant studies) |
Modified | ||
| 205261 | Third Party Disclosures |
Removed | ||
| 205260 | IDE Recordkeeping |
Modified |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0078 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202104-0910-011 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |