1. Within 10 Working Days
Submit an annual report by mail. Complete and submit Form FDA 3419 by January 1st of the year following the event(s).
FDA mandatory reporting requirements:
Instructions for completing:
Laws: 21 CFR §§ 803.10, 803.12(b), 803.30-33.
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
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.