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/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 and Healthcare 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.

Mandatory Reporting for Regulated Industry and User Facilities

The MedWatch Form FDA 3500A is used for the submission of adverse experience reports and reports of product problems required under the Food, Drug, and Cosmetic Act (FDCA) or by FDA regulations by entities such as user facilities, distributors, importers, applicants, and manufacturers.

However, please note that Form FDA 3500A may not be used for the submission of any postmarketing adverse experience reports required under 21 CFR 310.305, 314.80, 314.98, and 600.80 and under sections 503B or 760 of the FDCA.  These particular reports must be submitted in an electronic format that FDA can process, review, and archive.  See the final rule “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” (79 FR 33072)  at http://www.gpo.gov/fdsys/pkg/FR-2014-06-10/pdf/2014-13480.pdf and the companion guidance for industry “Providing Submissions in Electronic Format —Postmarketing Safety Reports”.

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