Application of IDE Regulation on In Vitro Diagnostic devices

Many in vitro diagnostic (IVD) devices are exempt from the IDE regulations. It includes diagnostic devices if the testing:

• is noninvasive;
• does not require an invasive sampling procedure that presents significant risk;
• does not by design or intention introduce energy into a subject; and
• 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 exempt from 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."

Studies which are exempt from the requirements of the IDE regulation are not exempt from the requirements for IRB review and approval under Part 56 and the requirements for obtaining informed consent under Part 50.