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
Special Controls complaint logs New 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: 2130295 223368 0  
To view an IC, click on IC Title