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
Jun 02
FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
Medical Devices
Jun 02
UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Medical Devices
Aug 25
Asiaticon SA de CV Issues Voluntary Nationwide Recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels
Drugs