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⚠️ Notice: This information collection may be outdated.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 Name	Status
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) Form	Unchanged
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) Form	Unchanged
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form	Unchanged
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form	Unchanged
0511 MDUFA Program to add APs formerly under 0510 83C MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-12
0511 MDUFA Program to add APs formerly under 0510 83C MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-12
0511_Supporting Statement_2021.docx Supporting Statement A	2021-08-16
0511_Supporting Statement_2021.docx Supporting Statement A	2021-08-16

IC Document Collections

IC ID	Document Title	Status
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