The definition of an “applicable de

The definition of an “applicable device clinical trial” states that the trial must be “ a prospective clinical study of health outcomes comparing a device subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device,or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not health outcomes).”