Manufacturer Reporting

Medical Devices; Medical Device Reporting; Manufacturer Reporting; Importer Reporting, User Facility Reporting, Distributor Reporting

OMB: 0910-0437

IC ID: 6116

Documents and Forms
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Information Collection (IC) Details

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Manufacturer Reporting
 
No Unchanged
 
Mandatory
 
21 CFR 803.53 21 CFR 803.52 21 CFR 803.50

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

Health Consumer Health and Safety

 

1,240 150
   
Private Sector Businesses or other for-profits
 
   99 %

  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 252,960 0 0 0 0 252,960
Annual IC Time Burden (Hours) 25,296 0 0 0 0 25,296
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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