Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Exemptions Unchanged 224 224 0
Importer Reporting, Death and Serious Injury Unchanged 1500 525 0
Importer Reporting, Death and Serious Injury Unchanged 1 1 0
MDR Files Unchanged 1820 2730 0
MDR Procedures Unchanged 1820 6006 0
Manufacturer Reporting Unchanged 252960 25296 0
Supplemental Reports Unchanged 98700 9870 0
User Facility Annual Reporting FDA Form 3419 Modified 520 520 0 Form and Instruction 3419 User Facility Annual Report Form
User Facility Reporting Unchanged 3640 1274 0
Total burden requested under this ICR: 361185 46446 0  
To view an IC, click on IC Title