MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors

MedWatch: The FDA Medical Products Reporting Program

OMB: 0910-0291

IC ID: 5858

Information Collection (IC) Details

View Information Collection (IC)

MedWatch 3500 for VOLUNTARY reporting of adverse events, product problems and product use errors
 
No Modified
 
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 Medwatch 3500 VOLUNTARY.pdf No No Fillable Fileable

Health Public Health Monitoring

 

22,700 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 22,700 0 0 -613,416 0 636,116
Annual IC Time Burden (Hours) 13,620 0 0 -668,863 0 682,483
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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