SPECIAL REVIEW FOR CERTAIN DEVICES.

SEC. 202. SPECIAL REVIEW FOR CERTAIN DEVICES. Section 515(d) (21 U.S.C. 360e(d)) is amended— (1) by redesignating paragraph (3) as paragraph (4); and (2) by adding at the end the following: “(5) In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall provide review priority for devices— “(A) representing breakthrough technologies, “(B) for which no approved alternatives exist, “(C) which offer significant advantages over existing approved alternatives, or “(D) the availability of which is in the best interest of the patients.”.