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.
Form FDA 3500 - Voluntary Reporting (pdf) and Instructions for Completing Form FDA 3500
For use by healthcare professionals, consumers, and patients.
Form FDA 3500B - Voluntary Reporting for Consumers
A consumer-friendly version of the 3500 reporting form.
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.
Online Voluntary Reporting
Easy online reporting with a by Health Professionals and Consumers and Patients.
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
MedWatch Safety Alerts
Jan 07
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
Biologics
Mar 22
UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication
Medical Devices
Feb 16
Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris
Medical Devices