For devices, small feasibility trials and larger clinical trials of prototype devices with a
primary measure of feasibility rather than health outcomes are not applicable clinical
trials. 42 U.S.C. § 282(j)(1)(A)(ii). Under current guidance contained on NIH’s website a device trial is not an
applicable device clinical trial when the trial includes only de-identified human
specimens and does not include “human subjects” (a requirement to be considered an
applicable clinical trial). The website states: “For purposes only of the requirements
under 402(j) of the PHS Act, this definition of human subject does not apply to de identified
human specimens.
For drugs, phase 1 clinical investigations (defined in 21 C.F.R. § 312.21) are not
categorized as “applicable clinical trials.” 42 U.S.C. § 282(j)(1)(A)(iii). Uncontrolled
clinical investigations of drugs or devices also are not considered “applicable clinical
trials.”
