|The Office of Management and Budget is in the process of reauthorizing Form FDA 3500 and Form FDA 3500A. Both forms may continue to be used beyond their current 10/31/2008 expiration dates. It is expected that there will be no changes to the forms. When the forms are reauthorized with new expiration dates, the updated forms will be provided.
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.
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