Voluntary Malfunction Summary Reporting Program

Medical Device Reporting

OMB: 0910-0437

IC ID: 231473

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Voluntary Malfunction Summary Reporting Program
 
No Unchanged
 
Voluntary
 
21 CFR 803

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

Health Consumer Health and Safety

 

67 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 46,575 0 0 0 0 46,575
Annual IC Time Burden (Hours) 4,658 0 0 0 0 4,658
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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