Voluntary 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 you and your 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. Your 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 patient safety.

What to Report on an FDA 3500 Voluntary form

The FDA Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care, not events that occur during clinical trials under an Investigational New Drug (IND) application. Those mandatory reports are to be submitted to FDA as specified in the investigational new drug/biologic regulations or investigational device exemptions. For instructions on mandatory reporting, go to http://www.fda.gov/medwatch/getforms.htm .

To submit your voluntary report:

• You may complete the voluntary form 3500 online
• Call us at 1-800-FDA-1088 to report by telephone
• Download a copy of the form and either fax it to us at 1-800-FDA-0178 or mail it back using the postage-paid addressed form.

What Not to Report on an FDA 3500 Voluntary form

Vaccines Reporting, Veterinary Medicine Reporting and Internet Fraud

• Vaccine Adverse Event Reporting System (VAERS)
• Veterinary medicine product adverse event reporting: www.fda.gov/cvm/index/ade/adetoc.htm
• Report suspected unlawful sale of medical products on the Internet

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. These reports must be made on the MedWatch 3500A Mandatory Reporting Form. You can download the mandatory form as a .pdf document for printing. (At this time, MedWatch 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 at http://www.fda.gov/cdrh/mdr/.

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.

For applicable regulations and industry guidance on mandatory reporting for drug/biologic manufacturers, distributors, and packers, go to http://www.fda.gov/medwatch/report/mfg.htm

The MedWatch 3500A MANDATORY form is available online as a .pdf document for printing. (At this time, MedWatch does not have a 3500A form that can be submitted electronically).

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Center for Drug Evaluation and Research/Office of the Center Director/Safety Policy and Communication Staff Web page last revised by jlw December 30, 2005