THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.

SEC. 202. THIRD PARTY REVIEW OF PREMARKET NOTIFICATION. Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m) is amended— (1) in subsection (c), by striking “The authority” and all that follows and inserting the following: “The authority provided by this section terminates October 1, 2007.”; and (2) by adding at the end the following subsection: “(d) Report.—Not later than January 10, 2007, the Secretary shall conduct a study based on the experience under the program under this section and submit to the Committee on Energy and 116 STAT. 1610Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the findings of the study. The objectives of the study shall include determining— “(1) the number of devices reviewed under this section; “(2) the number of devices reviewed under this section that were ultimately cleared by the Secretary; “(3) the number of devices reviewed under this section that were ultimately not cleared by the Secretary; “(4) the average time period for a review under this section (including the time it takes for the Secretary to review a recommendation of an accredited person under subsection (a) and determine the initial device classification); “(5) the average time period identified in paragraph (4) compared to the average time period for review of devices solely by the Secretary pursuant to section 510(k); “(6) if there is a difference in the average time period under paragraph (4) and the average time period under paragraph (5), the reasons for such difference; “(7) whether the quality of reviews under this section for devices for which no guidance has been issued is qualitatively inferior to reviews by the Secretary for devices for which no guidance has been issued; “(8) whether the quality of reviews under this section of devices for which no guidance has been issued is qualitatively inferior to reviews under this section of devices for which guidance has been issued; “(9) whether this section has in any way jeopardized or improved the public health; “(10) any impact of this section on resources available to the Secretary to review reports under section 510(k); and “(11) any suggestions for continuation, modification (including contraction or expansion of device eligibility), or termination of this section that the Secretary determines to be appropriate.”.