How to report to FDA

This guide gives the ways to send a report to FDA. Each statement is from an FDA page, which the site read on 2 Oct 2026. The site gives links and no advice.

MedWatch

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
Source: FDA, Reporting Serious Problems to FDA. Content current as of 26 Sep 2025. The site read the page on 2 Oct 2026.

MedWatch Online Voluntary Reporting Form
Reporting Serious Problems to FDA, which lists the forms

The forms

Easy online, voluntary reporting for health professionals, patients, and consumers. A consumer-friendly version of the 3500 reporting form.
Source: FDA, Reporting Serious Problems to FDA. Content current as of 26 Sep 2025. The site read the page on 2 Oct 2026.

The online form page says that the forms are Form FDA 3500 for health professionals and Form FDA 3500B for consumers and patients.

Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA. Note that reporters can request, within the report, FDA not release their contact information to the manufacturer.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

By telephone

If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.
Source: FDA, Reporting Serious Problems to FDA. Content current as of 26 Sep 2025. The site read the page on 2 Oct 2026.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of 27 Mar 2025. The site read the page on 2 Oct 2026.

A problem with a medical device

The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA's Safety Information and Adverse Event Reporting Program.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of 27 Mar 2025. The site read the page on 2 Oct 2026.

See the FDA page Medical Device Reporting (MDR): How to Report Medical Device Problems.

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of 27 Mar 2025. The site read the page on 2 Oct 2026.

Reports to a manufacturer

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Other products

The FDA page "Reporting Serious Problems to FDA" lists separate ways to report a vaccine, a tobacco product and a product for animals.

An emergency

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.