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Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)
ICR 202401-0910-006
OMB: 0910-0511
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0511
ICR 202401-0910-006
( )
Forms and Documents
Document
Name
Status
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601)
Form
Modified
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a))
Form
Modified
0511_Supporting Statement_2024.docx
Supporting Statement A
2024-09-27
IC Document Collections
IC ID
Document
Title
Status
6227
Medical Device User Fee Cover Sheet (Form FDA 3601)
Form
Modified
268231
Notification of the intent to use an Accredited Person
Other-AP Program
New
259088
Requests for Information under 513(g) of the FFDCA
Other-Agency Guidance
Modified
258930
Request for Accreditation - Third Party Inspections
Other-Statutory Authority
Unchanged
248796
Device Facility User Fee Cover Sheet (Form FDA 3601(a))
Form
Modified
ICR Details
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