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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Exemptions
Unchanged
815
82
0
Importer Reporting, Death and Serious Injury - Reporting
Unchanged
49308
4931
0
Importer Reporting, Death and Serious Injury - Third-Party
Unchanged
2800
980
0
MDR Files
Unchanged
1799
2699
0
MDR Procedures
Unchanged
1799
5937
0
Manufacturer Reporting
Unchanged
1456884
145688
0
Postmarketing Safety Reporting for Combination Products
New
198
89
0
Special Controls complaint logs
Unchanged
10
30
0
Supplemental Reports
Unchanged
565458
56546
0
User Facility Annual Reporting FDA Form 3419
Unchanged
186
186
0
User Facility Reporting
Unchanged
4661
1631
0
Voluntary Malfunction Summary Reporting Program
Unchanged
46575
4658
0
Total burden requested under this ICR:
2130493
223457
0
To view an IC, click on IC Title