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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Exemptions
Modified
224
224
0
Importer Reporting, Death and Serious Injury
Modified
1
1
0
Importer Reporting, Death and Serious Injury
Modified
1500
525
0
MDR Files
Modified
1820
2730
0
MDR Procedures
Modified
1820
6006
0
Manufacturer Reporting
Modified
252960
25296
0
Supplemental Reports
Modified
98700
9870
0
User Facility Annual Reporting FDA Form 3419
Modified
520
520
0
Form and Instruction
3419
User Facility Annual Report Form
User Facility Reporting
Modified
3640
1274
0
Total burden requested under this ICR:
361185
46446
0
To view an IC, click on IC Title
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