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
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
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
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.
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
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).