If an investigator develops a home-grown device that will be inserted into the heart chamber during open-heart surgery to measure internal pressures, but there is no intent to diagnose, treat, cure mitigate a disease or affect the structure/function of the body (it will be used to assess different physiologic conditions to understand the pathologenesis of disease), is the research FDA-regulated? In other words, they want to develop a device for future research on heart conditions, but it does not meet the definition of a medical device. Does the IRB need to insist that this device is classified by the FDA? Or can the IRB approve the study, noting that the device is not a medical device.

For this type of clinical investigation, it would be highly recommended to get a written statement from the FDA regarding the applicability of the investigational device exemption regulations (21 CFR 812). Even if you are correct that the device as used should not be considered as meeting the FDA’s definition of a medical device, most IRB’s would focus their attention on the device’s status as home-grown (not approved) and device’s use during open-heart surgery and find it to be significant risk (requires an IDE) or else require a formal FDA determination. A statement from the FDA either concurring with your view or else labeling the use as non-significant risk would remove the question from the IRB and would ensure a more efficient IRB review process.