MedWatch Reporting Forms

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.

• Form FDA 3500 - Voluntary Reporting
  For use by healthcare professionals, consumers, and patients. Submit completed form using supplied postage-paid mailer or fax to 1-800-332-0178
  
  
• Form FDA 3500A - Mandatory Reporting
  For use by IND reporters, manufacturers, distributors, importers, user facilities personnel

About PDF Format Documents

PDF files are viewed with the free Acrobat Reader software from Adobe. To get the latest version of Acrobat Reader for your computer, click on the "Get Acrobat Reader" button below. A new browser window will open to the Adobe web site with step-by-step directions for downloading and installing Acrobat Reader.

MedWatch Home | Safety Info | Submit Report | How to Report | Download Forms | Join E-list | Articles & Publications | Comments | Partners
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

Center for Drug Evaluation and Research/Office of the Center Director/Safety Policy and Communication Staff
Web page last revised by jlw January 30, 2009