Reporting Adverse Experiences to FDA

Adverse Reactions - Product Quality Problems - Product Use Errors

Voluntary Reporting

Report serious adverse events online for human medical products, including potential and actual product use errors, product quality problems, and therapeutic inequivalence/failure. The introductory page features additional information and instructions.

• Reporting by Consumers
  
  
• Reporting by Health Professionals
  
  
• Reporting by Veterinarians and Animal Owners
  
  
• HIPAA Compliance for Reporters to FDA MedWatch

Mandatory Reporting

• OTC Products and Dietary Supplements
  
  
• Updated addresses for MedWatch to Manufacturer Program and 3500A facsimile approval
  
  
• Contact information for questions about mandatory reporting
  
  
• Where to send mandatory reporting forms
  
  
• Preparing a Facsimile of Form FDA 3500A
  
  
• Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
  • Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Adverse Reaction Reporting
    
    
• Submitting mandatory investigational new drug (IND) reports
  
  
• Medical Device Manufacturers, Importers, and User-facilities
  
  • Download Mandatory Reporting Form 3500A (PDF format)
    
    
  • Information about medical device reporting
    This CDRH page provides contact information and answers to questions about mandatory device reporting
    
    
• Referencing FDA's MedWatch Program

Access to FDA Safety Data

MedWatch Home | Safety Info | Submit Report | How to Report | Download Forms | Join E-list | Articles & Publications | Comments | Partners
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Center for Drug Evaluation and Research/Office of the Center Director/Safety Policy and Communication Staff
Web page last revised by jlw May 30, 2008