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 1^st 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:

• Manufacturers, importers and device user facilities

Instructions for completing:

• Form 3500A
• Form FDA 3419

Electronic submissions:

• Electronic Medical Device Reporting
• Guidance
• FDA gateway

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.

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