MedWatch Forms for FDA Safety Reporting

Voluntary Reporting For use by Health Professionals, Consumers, and Patients

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

MedWatch for Health Professionals FDA Form 3500 pdf

Form FDA 3500 - Voluntary Reporting (pdf) and Instructions for Completing Form FDA 3500
For use by healthcare professionals, consumers, and patients.

MedWatch Forms for Patients and Consumers FDA Form 3500B pdf

Form FDA 3500B - Voluntary Reporting for Consumers
A consumer-friendly version of the 3500 reporting form.

MedWatch for Industry FDA Form 3500A pdf

Form FDA 3500A - Mandatory Reporting and Instructions for Completing Form FDA 3500A
Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel.

MedWatch Online Reporting for Health Professionals, Patients and Consumers

Online Voluntary Reporting
Easy online reporting with a by Health Professionals and Consumers and Patients.

Denuncia Voluntaria del Consumer Formulario FDA 3500b

Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B (En Español).
Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo.

Where to Report Other FDA Regulated Product Safety Information

Other products that the FDA regulates include Tobacco Products, Vaccines, and Animal Drugs, Devices and Food, including Pet Food. These products utilize different reporting pathways. It is recommended that reports concerning these products be submitted directly to the appropriate portals below.

• Tobacco, E-cigarettes or Vaping: Report problems or adverse health events and tobacco product problems to include problems with e-cigarettes (also known as “vapes”), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus. Report issues to the Safety Reporting Portal.
• Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS).
• Animal Drug, Device, Pet Food and Livestock Feed Problems: Report a Problem to the Center for Veterinary Medicine.

Note that submissions for these products through MedWatch will be accepted and directed to the correct.

Resources For You

• Join MedWatch Alerts E-list
• Reporting Unlawful Sales of Medical Products on the Internet
• MedWatchLearn