Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Exemptions Modified 815 82 0
Importer Reporting, Death and Serious Injury - Reporting Modified 49308 4931 0
Importer Reporting, Death and Serious Injury - Third-Party Modified 2800 980 0
MDR Files Modified 1799 2699 0
MDR Procedures Modified 1799 5937 0
Manufacturer Reporting Modified 1456884 145688 0
Supplemental Reports Modified 565458 56546 0
User Facility Annual Reporting FDA Form 3419 Modified 186 186 0
User Facility Reporting Modified 4661 1631 0
Voluntary Malfunction Summary Reporting Program Modified 46575 4658 0
Total burden requested under this ICR: 2130285 223338 0  
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