H. Investigational Medical Devices

When research is conducted to determine the safety or effectiveness of a device:  The device fulfills one of the IDE exemption categories: 

1. A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time. 
2. A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence. 
3. A diagnostic device, if the sponsor complies with applicable requirements in 21 CFR 809.10(c) and 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 participant, is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure, a device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put participants at risk.   A custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.