"Investigational drug, biological product, or device"

Sec. 2. As used in this chapter, "investigational drug, biological product, or device" means an investigational or experimental: (1) drug; (2) biological product; or (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.