MedWatch Forms for FDA Safety Reporting
Voluntary Reporting
Heath professionals, consumers and patients can submit voluntary reports using MedWatch Online 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.
- Online Voluntary Reporting
- Form FDA 3500 - Voluntary Reporting and Instructions for Completing Form FDA 3500 Designed for use by healthcare professionals
- Form FDA 3500B - Voluntary Reporting for Consumers/Patients
A consumer/patient-friendly version of the 3500 reporting form. - 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.
Mandatory Reporting
FDA Form 3500A is to be used only when electronic submission is not required. In such instances industry, user facilities personnel, and Investigational New Drug (IND) researchers may use the FDA Form 3500A to submit mandatory reports of adverse events and device malfunctions.
- Form FDA 3500A - Mandatory Reporting and Instructions for Completing Form FDA 3500A
Mandatory reporting. For use by IND researchers, manufacturers, distributors, importers, user facilities personnel.
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
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