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.
About PDF Format Documents
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