Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to FDA through MedWatch. The instructions on this webpage apply to both consumers and healthcare professionals who are submitting reports on a voluntary basis, and to certain entities with mandatory reporting obligations under FDA regulations.

Voluntary Reporting by Consumers, Patients and Health Professionals

In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

If the link to the PDF voluntary reporting form (below) does not automatically open the form in your browser, try installing the latest version of the free Adobe Acrobat Reader.

 

Resources For You

• Where to Send Completed Form FDA 3500A MANDATORY Reporting Form
• Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
• Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting
• HIPAA Compliance for Reporters to FDA MedWatch