IDE Sponsor Responsibilities - Documentation

Sponsor records

The sponsor must maintain accurate and complete records relating to the investigation. These records include:

• all correspondence including required reports,
• records of shipment of the device,
• records of disposition of the device
• signed investigator agreements including financial disclosure information,
• records concerning complaints and adverse device effects whether anticipated or not,
• any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.

Sponsor Reports

The sponsor must provide the following reports in a timely manner to FDA, the IRB's, and/or the investigators:

• Unanticipated Adverse Device Effects
• of IRB Approval
• Withdrawal of FDA Approval
• Current List of Investigators
• Progress Reports
• Recalls and Device Disposition
• Final Report
• Informed consent
• Significant Risk Device Determination
• Other Reports