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Medical Product Safety Information

MedWatch - your FDA gateway for clinically important safety information and reporting serious problems with human medical products

Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritional Products and Cosmetics)

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

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.

For Use By Form

Health Professionals, Patients, and Consumers
Easy online, voluntary reporting for health professionals, patients, and consumers.

Online Reporting Form

Health Professionals
For use by healthcare professionals, consumers, and patients.

Form FDA 3500 - Voluntary Reporting (pdf)

Instructions for Completing Form FDA 3500

Patients and Consumers
A consumer-friendly version of the 3500 reporting form.

Form FDA 3500B - Voluntary Reporting for Consumers (pdf)

Mandatory reporting for use by IND reporters, manufacturers, distributors, importers, user facilities personnel.

Form FDA 3500A - Mandatory Reporting (pdf)

Instructions for Completing Form FDA 3500A (pdf)

Denuncia Voluntaria del Consumer Formulario
Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo.

Formulario FDA 3500B (En Español)

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Clinically important and timely information about the drugs and devices you use, prescribe, or dispense every day, delivered to your email from the FDA.