Information Collection Request
Medical Devices; Humanitarian Use Devices
ICR 202303-0910-005 · OMB 0910-0332 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0332 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3674 Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) |
Form | New | Available |
| Form FDA 3674 Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) |
Form | New | Missing upstream |
 83-C for 0332 to add certification element under 0616 MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-12 | Available |
| 83-C for 0332 to add certification element under 0616 MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-12 | Missing upstream |
| 0332_Supporting Statement_2022.docx |
Supporting Statement A | Uploaded 2022-09-09 | Available |
| 0332_Supporting Statement_2022.docx |
Supporting Statement A | Uploaded 2022-09-09 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 5922 |  Medical Devices; Humanitarian Use Devices |
Unchanged | ||
| 258995 | Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) |
Form | New | |
| 258995 | Certification of Compliance with 42 U.S.C. § 282(j)(5)(B) |
Form | New | |
| 255790 | Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements |
Other-Agency Guidance | Unchanged |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0332 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202202-0910-005 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 2023-03-13 |
| Requested Expiration Date | 1969-12-31 |