* IMPORTANT * You may continue to use Form FDA 3500 (voluntary), Form FDA 3500B (consumer-friendly), and FDA 3500A (mandatory) past the listed expiration date, while the reporting forms are under review for renewal by the US Office of Management and Budget.
PDF format Reporting Forms
These forms are fillable on your computer using the free Adobe Acrobat Reader, or just print the blank form and fill it out by hand. The Voluntary Form FDA 3500 features a postage-paid pre-addressed mailer.
Instructions for Completing Form FDA 3500
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.
To report adverse events with tobacco products or dietary supplements online, use the Safety Reporting Portal.
For additional information about problem reporting: