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U.S. Department of Health and Human Services


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Download Forms

PDF format Reporting Forms

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

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.

To report adverse events with tobacco products or dietary supplements online, use the Safety Reporting Portal.

For additional information about problem reporting: