Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY report

MedWatch: The FDA Medical Products Reporting Program

OMB: 0910-0291

IC ID: 216797

Information Collection (IC) Details

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Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY report
 
No New
 
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 FDA-3500A.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

599 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 58,702 0 58,702 0 0 0
Annual IC Time Burden (Hours) 71,029 0 71,029 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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