Medical Devices: Medical Device Reporting, User Facility Reporting, Distributor Reporting, Manufacturer Reporting, Certification, Registration

MEDICAL DEVICES: MEDICAL DEVICE REPORTING, USER FACILITY REPORTING, DISTRIBUTOR REPORTING, MANUFACTURER REPORTING, CERTIFICATION, REGISTRATION

OMB: 0910-0059

IC ID: 165409

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MEDICAL DEVICES: MEDICAL DEVICE REPORTING, USER FACILITY REPORTING, DISTRIBUTOR REPORTING, MANUFACTURER REPORTING, CERTIFICATION, REGISTRATION
 
No Migrated
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA-2891 No No
Form 2891A, 2892 No No
Form 3322 & 3375 No No


    

44,650 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 46,800 0 0 -182,022 0 228,822
Annual IC Time Burden (Hours) 200,929 0 0 -77,058 0 277,987
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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