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Download Forms
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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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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. (Send only page 1 plus any continuation pages - do not send instruction pages)
- Instructions for Completing Form FDA 3500
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Form FDA 3500A - Mandatory Reporting
- For use by IND reporters, manufacturers, distributors, importers, user facilities personnel
- Instructions for Completing Form FDA 3500A
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.
Contact Us
- 1-800-332-1088
- 1-800-FDA-0178 Fax
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787