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All industry-sponsored device trials must be reviewed by the Implant and Investigational Device Committee (IIDC) for investigators located at UWMC and by the Surgical Council (SC) for investigators located at Harborview. The purpose of these reviews is to:

• Ensure that any device that has not been cleared for marketing by the FDA has an approved IDE (Investigational Device Exemption) before the study is initiated. For information on FDA policy and guidelines regarding the testing of investigational devices, see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

• Assure compliance with Medicare billing regulations. Medicare will reimburse costs (e.g., device, physician fees, inpatient services) incurred during a clinical trial only for certain categories of device.  Improper billing can lead to organizational as well as individual liability. For more information on Medicare reimbursement for investigational devices, see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080302.htm