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  • Reporting by Health Professionals

  • Reporting by Health Professionals

    Voluntary Reporting by Health Professionals

    Thank you for visiting the MedWatch website to voluntarily report a serious adverse event , product problem or medication error that you suspect is associated with the use of an FDA-regulated drug, biologic, 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 this 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 IND clinical trials or other clinical studies. 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 .

    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 and Veterinary Medicine Reporting

    Vaccine Adverse Event Reporting System (VAERS)

    Veterinary medicine product adverse event reporting:

    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

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

    Mandatory Drug/Biologic 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

    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).

    If you submit reports frequently, you may download a fillable version of the FDA 3500A form for local installation on your personal computer.

    This information came from an FDA online article.

    *** Any law, statute, regulation or other precedent is subject to change at any time ***

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