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

MedWatch: The FDA Medical Products Reporting Program

OMB: 0910-0291

IC ID: 216800

Information Collection (IC) Details

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Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
 
No New
 
Voluntary
 
21 CFR 301

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors FDA-3500.pdf Yes Yes Fillable Fileable

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

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