Importer Reporting, Death and Serious Injury

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

OMB: 0910-0437

IC ID: 202633

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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Importer Reporting, Death and Serious Injury
 
No Unchanged
 
Mandatory
 
21 CFR 803.40 21 CFR 803.42

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

Health Consumer Health and Safety

 

1 0
   
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 1 0 0 0 0 1
Annual IC Time Burden (Hours) 1 0 0 0 0 1
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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