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Safety

Download Forms

The Office of Management and Budget has reauthorized Form FDA 3500 and Form FDA 3500A through 12/31/2011.


Online Reporting Form (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.

PDF format Reporting Forms (with built-in instructions)

These forms are fillable on your computer using the free Adobe Acrobat Reader. You can also choose to just print the blank form, and fill it out by hand. The Voluntary Form FDA 3500 features a postage-paid pre-addressed mailer.

 

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Contact Us

  • 1-800-332-1088
  • 1-800-FDA-0178 Fax
  • MedWatch Online

    Regular Mail: Use postage-paid FDA Form 3500

    Mail to: MedWatch 5600 Fishers Lane

    Rockville, MD 20852-9787

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