Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.  Unexpected fatal or life-threatening suspected adverse events must be reported to the FDA as soon as possible but no later than within 7 calendar days of first being notified of the event.

Follow-up reporting: Any relevant additional information obtained related to the initial report should be submitted as a Follow-up Safety Report and must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.

Adverse events that don’t meet these categories should be submitted with your annual report with a summary of all events that have occurred.

Initial reporting: Any unanticipated adverse event suspected to be caused/associated with a device must be reported to the FDA and the reviewing IRB within 10 working days of the event.

Follow up reporting: Any relevant additional information obtained related to the initial report should be submitted as a Follow-up Safety Report and must be reported to the FDA as soon as possible.

Adverse events that don’t meet these categories should be submitted with your annual report with a summary of all events that have occurred.