IDE Reports

Sponsor Reports

All reports to FDA should be identified as IDE Supplements and submitted in triplicate.

• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Withdrawal of FDA Approval
• Current List of Investigators
• Progress Reports or Annual Reports
• Recalls and Device Disposition
• Final Report
• Informed consent
• Significant Risk Device Determination
• Other Reports: The sponsor must provide accurate, complete, and current information about any aspect of the investigation upon request from the reviewing IRB or FDA.

Investigator Reports

The investigator must provide the following reports in a timely manner:

• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Progress Reports
• Deviations from the Investigational Plan
• Informed Consent: If an investigator uses a device without obtaining informed consent, the investigator must report the used to the sponsor and to the reviewing IRB within 5 working days after the use occurs.
• Final Report
• The investigator must submit a final report to the sponsor and to the reviewing IRB within 3 months after termination or completion of the investigation.
• Other Reports: The investigator must provide accurate, complete, and current information about any aspect of the investigation upon request from the reviewing IRB or FDA.