An IRB is solely required to make a determination of SR or NSR for an investigational medical device study This determination is not required for studies that are exempt from the IDE regulations (e.g., where a device is approved or cleared and used in accordance with its approved/cleared indication). The decision of what needs to be documented in IRB meeting minutes depends on the IRB procedures. As a best practice, it is best to document the device status in the study for all device studies. However, documentation of SR or NSR determination is only required for investigational medical device studies as noted in the above-referenced guidance document.
In the US, if a 510(k) device is used in a study, but it’s not being used within the approved indication, could the FDA help the researcher determine whether the device is SR (needs an IDE) or NSR? OR should the IRB just err on the side of a SR finding and require the researcher obtain an IDE.
