Page:United States Statutes at Large Volume 111 Part 3.djvu/255

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2343 "(1) PROGRAMS.— The Secretary shall provide for such accreditation through programs administered by the Food and Drug Administration, other government agencies, or by other qualified nongovernment organizations. " (2) ACCREDITATION.— "(A) IN GENERAL.—Not later than 180 days after the Federal Register, date of the enactment of the Food and Drug Administration publication. Modernization Act of 1997, the Secretary shall establish and publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in subsection (a). The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The accreditation of such person shall specify the particular activities under subsection (a) for which such person is accredited. " (B) WITHDRAWAL OF ACCREDITATION. — The Secretary may suspend or withdraw accreditation of any person accredited under this paragraph, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this section. "(C) PERFORMANCE AUDITING. — TO ensure that persons accredited under this section will continue to meet the standards of accreditation, the Secretary shall— "(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such person; and "(ii) take such additional measures as the Secretary determines to be appropriate. "(D) ANNUAL REPORT.— The Secretary shall include in the annual report required under section 903(g) the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year. "(3) QUALIFICATIONS.— An accredited person shall, at a minimum, meet the following requirements: "(A) Such person may not be an employee of the Federal Government. "(B) Such person shall be an independent orgemization which is not owned or controlled by a manufacturer, supplier, or vendor of devices and which has no organizational, material, or financial affiliation with such a manufacturer, supplier, or vendor. "(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation. "(D) Such person shall not engage in the design, manufacture, promotion, or sale of devices. "(E) The operations of such person shall be in accordance with generally accepted professional sind ethical business practices and shall agree in writing that as a minimum it will— "(i) certify that reported information accurately reflects data reviewed;

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