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  1. Medical Product Safety Information

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.

MedWatch Reporting Forms

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.

Resources For You

MedWatch safety alerts delivered to you

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