MedWatch Reporting Forms

Standard Reporting Forms

• FDA Form 3500 - Voluntary Reporting
  For use by: Healthcare professionals, consumers, and patients
  Instructions for completing the 3500 form
  
  
• FDA Form 3500A - Mandatory Reporting
  For use by: IND Reporters, manufacturers, distributors, importers, user facilities personnel
  Instructions for completing the 3500A form

Fillable Reporting Forms (with built-in instructions)

The forms below are fillable on your computer using Adobe Acrobat. Saving and/or retrieving your data can only be done using the full version of Acrobat or Adobe Approval, not with the free Acrobat Reader.

• Form 3500 - Voluntary Reporting
  For use by: Healthcare professionals, consumers, and patients
  
  
• Form 3500A - Mandatory Reporting
  For use by: IND Reporters, manufacturers, distributors, importers, user facilities personnel

MedWatch reporting forms and many other documents on the MedWatch site are available in PDF (Acrobat) format. PDF (short for Portable Document Format) documents can be viewed and printed on a variety of computer platforms, exactly as they were intended to appear. The symbol indicates an Acrobat file.

PDF files are viewed with the free Acrobat Reader software from Adobe. If you do not have Acrobat Reader installed on your computer, click on the "Get Acrobat Reader" button below, and a new browser window will open to the Adobe web site with step-by-step directions for downloading and installing Acrobat Reader.

Download and/or view the MedWatch reporting form(s) on your computer from the links above.

PC users: right click the link and select "Save Target As.." (IE 4/5/6 users) or "Save As..." (Netscape 4/6 users).

Mac users: click and hold the link and select "Download Link to disk..." (IE4/5) or "Save This Link As..." (Netscape 4+).