1. Home
  2. FDA: Device [Text-based]

How to report device-related adverse events to the Food and Drug Administration

1. Within 10 Working Days

  • Report a death to both the FDA and the manufacturer (if known).
  • Report a serious injury to the manufacturer only. If the manufacturer is not known, report to the FDA.
  • There are 2 alternate ways to submit a report to the FDA:
    1. Complete and mail paper form FDA 3500A; or
    2. Use FDA's Electronic Submissions Gateway to submit an electronic version of form FDA 3500A.

2. Annually

Submit an annual report by mail. Complete and submit Form FDA 3419 by January 1st of the year following the event(s).

Tips:

  • In addition to these reporting requirements, if you believe there is a public health emergency, you may notify FDA’s Office of Crisis Management, Emergency Operations Center by phone at 301-796-8240 or 866-300-4374, followed by an email to: emergency.operations@fda.hhs.gov.
  • If multiple patients were involved in the same incident, use only one Form 3500A. Follow the instructions for reporting an incident with multiple patients.
  • In the case of device malfunctions that do not result in serious injury, you may voluntarily report the event through MedWatch, the FDA’s safety information and adverse event reporting program.


Resources:

FDA mandatory reporting requirements:

Instructions for completing:

Electronic submissions:

Laws: 21 CFR §§ 803.10, 803.12(b), 803.30-33.


Contact:

Food and Drug Administration,
Center for Devices and Radiological Health
Medical Device Reporting
P.O. Box 3002
Rockville, MD 20847-3002
Phone: (301) 796-6670
Email: MDRPolicy@fda.hhs.gov


We hope these instructions helped you meet this reporting requirement. Be aware that this action may not fulfill all applicable reporting requirements associated with the event.

This document is intended for informational purposes only and does not constitute regulatory guidance or legal advice. Links and information in this document may be outdated. BLC does not represent or warrant that this information is accurate, complete, or current. For further terms and conditions, see the Terms of Use.