Information Collection Request
Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)
ICR 202303-0910-002 · OMB 0910-0511 · Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0511 can be found here:
Forms and Documents
| Document | Type | Status | Availability |
|---|---|---|---|
 Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) |
Form | Unchanged | Available |
| Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) |
Form | Unchanged | Available |
| Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a)) |
Form | Unchanged | Available |
| Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a)) |
Form | Unchanged | Repair queued |
 0511 MDUFA Program to add APs formerly under 0510 83C MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-12 | Available |
| 0511 MDUFA Program to add APs formerly under 0510 83C MARCH 2023.docx |
Justification for No Material/Nonsubstantive Change | Uploaded 2023-03-12 | Repair queued |
| 0511_Supporting Statement_2021.docx |
Supporting Statement A | Uploaded 2021-08-16 | Repair queued |
| 0511_Supporting Statement_2021.docx |
Supporting Statement A | Uploaded 2021-08-16 | Repair queued |
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 6227 |  Medical Device User Fee Cover Sheet (Form FDA 3601) |
Form | Unchanged | |
| 6227 | Medical Device User Fee Cover Sheet (Form FDA 3601) |
Form | Unchanged | |
| 259088 | Requests for Information under 513(g) of the FFDCA |
Other-Agency Guidance | New | |
| 258930 | Request for Accreditation - Third Party Inspections |
Other-Statutory Authority | New | |
| 248796 | Device Facility User Fee Cover Sheet (Form FDA 3601(a)) |
Form | Unchanged | |
| 248796 | Device Facility User Fee Cover Sheet (Form FDA 3601(a)) |
Form | Unchanged |
ICR Details
| Status | Active |
|---|---|
| Agency/Subagency | HHS/FDA |
| OMB Control No | 0910-0511 |
| Type of Information Collection | No material or nonsubstantive change to a currently approved collection |
| Previous ICR Reference No | 202107-0910-002 |
| Agency Tracking No | CDRH |
| Date Submitted to OIRA | 2023-03-13 |
| Requested Expiration Date | 1969-12-31 |