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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
340
340
0
Importer Reporting, Death and Serious Injury - Reporting
Modified
578
578
0
Importer Reporting, Death and Serious Injury - Third-Party
Modified
14450
5058
0
MDR Files
Modified
1240
1860
0
MDR Procedures
Modified
1240
4092
0
Manufacturer Reporting
Modified
337900
33790
0
Supplemental Reports
Modified
135146
13515
0
User Facility Annual Reporting FDA Form 3419
Modified
159
159
0
User Facility Reporting
Modified
5231
1831
0
Voluntary Malfunction Summary Reporting Program
New
67543
6755
0
Total burden requested under this ICR:
563827
67978
0
To view an IC, click on IC Title