Ind. Code § 16-42-26-2
As used in this chapter, "investigational drug, biological product, or device" means an investigational or experimental:
(3) medical device;
that has successfully completed Phase I of a federal Food and Drug Administration approved clinical trial, but has not been approved for general use by the federal Food and Drug Administration and remains under investigation in a clinical trial.
As added by P.L.2-2015, SEC.3.