IDE Process: Safety Reports
The sponsor-investigator notifies the FDA and all participating investigators in a written IDE safety report of any Unanticipated Adverse Device Effects. The report is also provided to the device manufacturer and to the reviewing IRB as soon as possible, but no later than 10 working days after the Investigator first learns of the effect (per FDA regulations CFR 21 Part 812.150). Thereafter the sponsor-investigator shall submit such additional reports concerning the effect as FDA requests.
On an annual basis as part of the update to the study IDE, the sponsor-investigator need to submit to the FDA and the IRB:
• A summary of all IDE Unanticipated Adverse Device Effect reports submitted during the past year.
• A list of all subjects who died during the participation in the investigation listing cause of death for each.
• A list of subjects who dropped out during the course of the investigation in association with any unanticipated device effect, whether or not thought to be device related.
• IDE Unexpected Device Effect reports should include the following information: Subject identification number and initials, investigator’s name and medical facility, subject’s date of birth, gender, ethnicity, date of implant (if applicable), date/time of onset, a complete description of the event, severity, duration, actions taken and event outcome, e.g. date of resolution or death.