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  1. Reporting Serious Problems to FDA

Reporting By Health Professionals

A Message About HIPAA Compliance for Reporters to FDA MedWatch

Thank you for visiting the MedWatch website to voluntarily report a serious adverse event, product quality problem or product use error that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device or dietary supplement.

In order to keep effective drugs and devices available on the market for use by patients, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of all FDA-regulated products. You and your patients report may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the drug or device and leads to increased safety.

What to Report on Form FDA 3500 and FDA 3500B Voluntary Adverse Event Report Form

FDA Form 3500 should be used by healthcare professionals and FDA Form 3500B should be used by patients or consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care. (Events that occur during clinical trials under an Investigational New Drug (IND) application are mandatory reports and are submitted to FDA as specified in the investigational new drug/biologic regulations or investigational device exemptions.) To submit your voluntary report:

What Not to Report on Form FDA 3500

Vaccines Reporting, Veterinary Medicine, Tobacco Products Reporting and Internet Fraud

Mandatory Device Reporting

User-facilities such as hospitals and nursing homes are legally required to report suspected medical device-related deaths to both FDA and the manufacturer, if known, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown.

Mandatory reports are made using Form FDA 3500A Mandatory Reporting Form. You can download the mandatory form as a .pdf document for printing. (At this time, FDA does not have a 3500A form that can be submitted electronically).

For more information, see the FDA Center for Devices and Radiological Health (CDRH) Reporting page.

Health professionals within user-facilities should familiarize themselves with their institution's procedures for this mandatory reporting process. 

Mandatory Drug/Biologic Reporting (including IND, BLA Reporting)

Adverse events that occur during clinical studies are to be reported to FDA as specified in the investigational new drug/biologic regulations. Please refer to applicable regulations and industry guidance on mandatory reporting for drug/biologic manufacturers, distributors, and packers.

Form FDA 3500A Mandatory Reporting form is available online as a .pdf document for printing.  If you submit reports frequently, download a fill-able version of the FDA 3500A form for local installation on your personal computer.

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