Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Certificate of Compliance w/42 CFR part 11 Modified 61 46 0
Premarket Approval of Medical Devices: Maintenance of Records Modified 1720 29240 0
Premarket Approval of Medical Devices: Reporting Modified 43918 1182270 0 Other-Agency Guidance - Providing Information about Pediatric Uses of Medical Devices
Other-Agency Guidance_Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Total burden requested under this ICR: 45699 1211556 0  
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