Any Phase II-IV drug/biologic trial that is a controlled clinical investigation that investigates a drug that falls under FDA jurisdiction (ie, applicable clinical trial) must be registered whether for an approved or unapproved product/use/indication. Device studies that are prospective clinical studies of health outcomes AND compares an intervention with a device against a control in human subjects AND is subject to Section 510(k), 515, 520(m) of the FDC Act AND is NOT a small device feasibility study or clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not health outcomes must be registered.
