Page:United States Statutes at Large Volume 111 Part 3.djvu/248

 Ill STAT. 2336 PUBLIC LAW 105-115—NOV. 21, 1997 "(B) The Secretary may request, at any time, the data or information rehed on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). "(C) A person making a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of two years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.". (b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended by adding at the end the following: "(x) The falsification of a declaration of conformity submitted under section 514(c) or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section ". (c) SECTION 501. —Section 501(e) (21 U.S.C. 351(e)) is amended— (1) by striking "(e)" and inserting "(e)(1)"; and (2) by inserting at the end the following: "(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.". (d) CONFORMING AMENDMENTS.— Section 514(a) (21 U.S.C. 360d(a)) is amended— (1) in paragraph (1), in the second sentence, by striking "under this section" and inserting "under subsection (b)"; (2) in paragraph (2), in the matter preceding subparagraph (A), by striking "under this section" and inserting "under subsection (b)"; (3) in paragraph (3), by striking "under this section" and inserting "under subsection (b)"; and (4) in paragraph (4), in the matter preceding subparagraph (A), by striking "this section" and inserting "this subsection and subsection (b)". SEC. 205. SCOPE OF REVIEW; COLLABORATIVE DETERMINATIONS OF DEVICE DATA REQUIREMENTS. (a) SECTION 513(a).— Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at the end the following: "(C) In making a determination of a reasonable assurance of the effectiveness of a device for which an application under section 515 has been submitted, the Secretary shall consider whether the extent of data that otherwise would be required for approval of the application with respect to effectiveness can be reduced through reliance on postmarket controls. "(D)(i) The Secretary, upon the written request of any person intending to submit an application under section 515, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate for purposes of approval of an application the effectiveness of a device for the conditions of use proposed by such person. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan for determining whether there is a reasonable assurance of effectiveness, and, if available.

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