Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)

MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)

OMB: 0910-0291

IC ID: 216800

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Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
 
No Modified
 
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

 

5,233 0
   
Private Sector Businesses or other for-profits
 
   20 %

  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 5,233 0 0 0 0 5,233
Annual IC Time Burden (Hours) 3,454 0 0 0 0 3,454
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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