Information Collection Request
Medical Device Labeling Regulations; Unique Device Identification
ICR 202301-0910-017 · OMB 0910-0485 · Received in OIRA
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0485 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 0485 Medical Device Labeling to add UDI 2023 SSA.docx |
Supporting Statement A | Uploaded 2023-02-26 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 258774 |  Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile |
New | ||
| 258139 | Labeling requirements for UDI |
New | ||
| 255349 | OTC Hearing Aids Final Rule - New Requirements |
Other-Agency Guidance | Unchanged | |
| 255348 | OTC Hearing Aids Final Rule - One Time Burden |
Unchanged |
ICR Details
| Status | Received in OIRA |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0485 |
| Type of Information Collection | Revision of a currently approved collection |
| Previous ICR Reference No | 202208-0910-007 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 1969-12-31 |
| Requested Expiration Date | 1969-12-31 |