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U.S. Department of Health and Human Services


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PDF format Reporting Forms (with built-in instructions)


* IMPORTANT * Form FDA 3500 [voluntary] and FDA 3500A [mandatory] presently show an expiration date of 12/31/2011. You may continue to use them while the reporting forms are under review for renewal by the US Office of Management and Budget. Mandatory reporters, see OMB Reginfo.gov page for submission status at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201112-0910-001


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.