IVD studies are exempt from IDE regulation if:
If your IVD study does not fit into one of the three categories listed, then you must have an approved IDE prior to beginning your investigation and any shipment of your investigational IVD. The requirements for the IDE will depend on the level of risk that the study presents to its subjects.
Note: If your device has been approved under a PMA or cleared under a 510(k) and then used in a study in accordance to that labeling, it is not subject to IDE regulation.