The determination of whether a tria

The determination of whether a trial is an “applicable clinical trial” has to be made by the sponsor/responsible party associated with that trial and familiar with all aspects of the clinical trial. FDA cannot make that determination for any party. 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).” Determinations of whether a trial meets this definition must take into consideration all the aspects of the trial, including whether the trial is studying health outcomes, is comparing a device against a control, and whether the trial falls into the specific exclusion described in the definition.