Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Exemptions New 228 684 0
Importer Reporting Malfunctions New 25 25 0
Importer Reporting, Death and Serious Injury New 1 1 0
MDR Files New 30000 45000 0
MDR Procedures New 220 2200 0
Manufacturer Reporting Modified 301077 301077 0
Supplemental Reports New 37448 37448 0
User Facility Annual Reporting FDA Form 3419 New 195 195 0 Form and Instruction 3419 User Facility Annual Report Form
User Facility Reporting New 4896 4896 0
Total burden requested under this ICR: 374090 391526 0  
To view an IC, click on IC Title