Page:United States Statutes at Large Volume 116 Part 2.djvu/828

 116 STAT. 1610 PUBLIC LAW 107-250—OCT. 26, 2002 Commerce 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.". SEC. 203. DEBARMENT OF ACCREDITED PERSONS. Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended by adding at the end the following subsection: "(m) DEVICES; MANDATORY DEBARMENT REGARDING THIRD- PARTY INSPECTIONS AND REVIEWS.— "(1) IN GENERAL. —If the Secretary finds that a person has been convicted of a felony under section 301(gg), the Secretary shall debar such person from being accredited under section 523(b) or 704(g)(2) and from carrying out activities under an agreement described in section 803(b). "(2) DEBARMENT PERIOD. —The Secretary shall debar a person under paragraph (1) for the following periods: "(A) The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent. "(B) The debarment of an individual shall be permanent.

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