IDE Records: Sponsor Records

Sponsor Records for Significant Risk Device Studies

These records include:

• all correspondence including required reports
• records of shipment of the device
• name and address of the consignee
• type and quantity of the device, date of shipment, and batch number or code
• records of disposition of the device
• batch number or code of any devices returned to the sponsor, repaired, or disposed of in other ways
• reasons for and the method of disposal
• 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 Records for Nonsignificant Risk Device Studies

The following records must be maintained in one location and available for FDA inspection:

• the name and intended use of the device
• the objectives of the investigation
• a brief explanation of why the device is not a significant risk device
• the name and address of each investigator
• name and address of each IRB
• a statement of the extent to which the good manufacturing practices (21 CFR 820) will be followed in manufacturing the device