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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.

• Form FDA 3500 - Voluntary Reporting

  • For use by healthcare professionals, consumers, and patients. Submit the completed form using supplied postage-paid mailer or fax to 1-800-332-0178
  • Instructions for Completing Form FDA 3500

• Form FDA 3500A - Mandatory Reporting

  • For use by IND reporters, manufacturers, distributors, importers, user facilities personnel
  • Instructions for Completing Form FDA 3500A