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