Premarket Approval of Medical Devices: maintenance of records

Premarket Approval of Medical Devices - 21 CFR Part 814

OMB: 0910-0231

IC ID: 209459

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Premarket Approval of Medical Devices: maintenance of records
 
No Modified
 
Mandatory
 
21 CFR 814.82

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

422 0
   
Private Sector Businesses or other for-profits
 
   95 %

  Approved 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 422 0 0 -185 0 607
Annual IC Time Burden (Hours) 7,174 0 0 -5,566 0 12,740
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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