Investigational Device Exemption (IDE)
Will your study involve the use of an investigational device?
No medical device (supplies, accessories, or equipment), whether purchased, contracted, donated, loaned or for trial, may be used in the Medical Center for inpatient or outpatient care purposes without first being evaluated by Clinical Engineering.
In order to obtain approval, complete and submit the on-line New Medical Device Monitoring Form to Clinical Engineering. If you have questions on how to complete the form, contact Clinical Engineering at 982-3857.
If the investigational device does not already have an Investigational Device Exemption (IDE), does it meet the FDA’s definition of a ‘significant risk device’? If so, a formal IDE submission to the FDA is required.
The FDA defines a Significant Risk Device as an investigational device that:
• Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
A non-significant risk (NSR) device is one that does not meet the definition of a significant risk device.
The sponsor of a Significant Risk (SR) device study is required to submit an IDE application to the FDA.
Refer to FDA ”Guidance for Institutional Review Boards and Clinical Investigators, Significant Risk and Nonsignificant Risk Medical Device Studies, 2006” for examples of non-significant and significant risk devices.
For assistance with compiling an IDE submission, contact the SOM Clinical Trials Office at 434-924-8570 or email@example.com.
Will your study involve the use of an investigational device for which the sponsor plans to bill a third party payor, specifically, Medicare?
If your study sponsor plans to charge for the investigational device (a device for which the FDA has issued an IDE) and related services, our local Medicare fiscal intermediary must provide their approval before UVa can submit any claims to Medicare. Palmetto GBA, UVa’s local Medicare fiscal intermediary contractor, has developed a submission process for clinical investigators to follow for requesting the necessary approval.