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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Medical Devices; Medical Device Reporting; Manufacturer reporting; importer reporting, user facility reporting, distributor reporting
Modified
135565
21525
23100000
Form and Instruction
3419
Medical Device Reporting Annual User Facility Report
Form and Instruction
FDA 3500A
Medical device Adverse Event Report
Instruction
Total burden requested under this ICR:
135565
21525
23100000
To view an IC, click on IC Title