Information Collection Request
Medical Device Reporting
ICR 202303-0910-015 · OMB 0910-0437 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0437 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 6116 |  Manufacturer Reporting |
Unchanged | ||
| 259221 | Postmarketing Safety Reporting for Combination Products |
New | ||
| 251675 | Special Controls complaint logs |
Unchanged | ||
| 231473 | Voluntary Malfunction Summary Reporting Program |
Unchanged | ||
| 202637 | Importer Reporting, Death and Serious Injury - Third-Party |
Unchanged | ||
| 202636 | MDR Files |
Unchanged | ||
| 202635 | MDR Procedures |
Unchanged | ||
| 202634 | Supplemental Reports |
Unchanged | ||
| 202633 | Importer Reporting, Death and Serious Injury - Reporting |
Unchanged | ||
| 202632 | User Facility Annual Reporting FDA Form 3419 |
Unchanged | ||
| 202631 | User Facility Reporting |
Unchanged | ||
| 202630 | Exemptions |
Unchanged |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0437 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202202-0910-015 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 2023-03-20 |
| Requested Expiration Date | 1969-12-31 |