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Information Collection

Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records

IC 192723 under ICR 202505-0910-005 · OMB 0910-0449.

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Recordkeeping Postmarket Surveillance of Medical Devices: manufacturer and investigator records
 
No Modified
 
Mandatory
 
21 CFR 822

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

Health Consumer Health and Safety

 

12 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 12 0 0 -8 0 20
Annual IC Time Burden (Hours) 105 0 0 -70 0 175
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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