MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting

MedWatch: The FDA Medical Products Reporting Program

OMB: 0910-0291

IC ID: 202917

Information Collection (IC) Details

View Information Collection (IC)

MedWatch 3500a for use by user-facilities, importers, distributors and manufacturers for MANDATORY reporting
 
No Removed
 
Mandatory
 
21 CFR 301

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3500a MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting MedWatch 3500a MANDATORY reporting.pdf Yes Yes Fillable Fileable

Health Public Health Monitoring

 

37,280 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 0 0 -752,573 0 0 752,573
Annual IC Time Burden (Hours) 0 0 -835,173 0 0 835,173
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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