Forms for Reporting to FDA
Voluntary Reporting For use by healthcare professionals, consumers, and patients.
These forms are available as fillable pdf's that you can print and either type or write important information on the form or you can use the online pathway to complete the required information. Report serious adverse events online for human medical products, including potential and actual product use errors, product quality problems, and therapeutic inequivalence/failure.
- 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 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B (En Español).
Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo.
Online Reporting Form (Voluntary Reporting)
For use by Health Professionals and Consumers and Patients
Mandatory Reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel
Tobacco: To report adverse events with tobacco products or dietary supplements, use the Safety Reporting Portal.
Dietary Supplements: To report adverse events with dietary supplements, use the Safety Reporting Portal.
Vaccines: To report adverse events with vaccines, use the Vaccine Adverse Event Reporting System (VAERS).
Animal Drugs: To report adverse drug experiences or product defects for animals, use FDA Form 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect.