Page:United States Statutes at Large Volume 111 Part 3.djvu/246

 Ill STAT. 2334 PUBLIC LAW 105-115—NOV. 21, 1997 essential to determining the safety or effectiveness of the device involved has been identified, "(C) A decision under subparagraph (B)(ii) by the director shall be in writing, and may be made only after the Secretary has provided to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the scientific issue involved.", (b) ACTION ON APPLICATION. —Section 515(d)(1)(B) (21 U.S.C. 360e(d)(l)(B)) is amended by adding at the end the following: "(iii) The Secretary shall accept and review statistically valid and reliable data and any other information from investigations conducted under the authority of regulations required by section 520(g) to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if— "(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or "(II) the data or information relates to a device approved under this section, is available for use under this Act, and is relevant to the design and intended use of the device for which the application is pending.". 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.". SEC. 203. EXPANDING HUMANITARIAN USE OF DEVICES. Section 520(m) (21 U.S.C. 360j(m)) is amended— (1) in paragraph (2), by adding after and below subparagraph (C) the following sentences: "The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application. "; (2) in paragraph (4)— (A) in subparagraph (B), by inserting after "(2)(A)" the following: ", unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient"; and (B) by adding after and below subparagraph (B) the following:

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