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Premarket Approval of Medical Devices: Reporting

IC 5826 under ICR 202602-0910-004 · OMB 0910-0231.

Documents and Forms
Document Name
Document Type
Other-Agency Guidance - Providing In
Other-Agency Guidance_Transition Pla
Information Collection (IC) Details

View Information Collection (IC)

Premarket Approval of Medical Devices: Reporting
 
No Modified
 
Mandatory
 
21 CFR 814

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance - Providing Information about Pediatric Uses of Medical Devices Guidance_Providing Information about Pediatric Uses of Medical Devices.pdf Yes Yes Fillable Fileable
Other-Agency Guidance_Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance_Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

6,476 500
   
Private Sector Businesses or other for-profits
 
   95 %

  Requested Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 43,918 0 0 40,474 3,444 0
Annual IC Time Burden (Hours) 1,182,270 0 0 838,804 343,466 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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