Reporting Serious Problems to FDA

Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use 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. 

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.

Voluntary Reporting for Consumers and Healthcare Professionals


Form FDA 3500A is a two-sided form. It is for use by user facilities, distributors, importers, applicants, and manufacturers for MANDATORY reporting of adverse events and product problems as designated in the applicable statutes and FDA regulations.

Page Last Updated: 03/12/2014
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