Do the IDE regulations apply to in vitro diagnostic devices?
Many in vitro diagnostic (IVD) devices are exempt from the IDE regulations. Under section ยง812.2(c) of the IDE regulation, studies exempt from the IDE regulation include diagnostic devices if the testing: 1) is noninvasive; 2) does not require an invasive sampling procedure that presents significant risk; 3) does not by design or intention introduce energy into a subject; and 4) is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; IVD devices that are under study, including IVD devices that are exemptfrom the IDE regulation, must comply with labeling requirements under 21 CFR 809.10(c)(2). One of two statements is required, as applicable for each case: “For Research Use Only. Not for use in diagnostic procedures”, or “For Investigational Use Only. The performance characteristics of this product have not been established.” INSTITUTIONAL REVIEW BOARD (IRB) Studies which are exempt from the requirements of the IDE reg
