ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET NOTIFICATION REPORTS.

SEC. 210. ACCREDITATION OF PERSONS FOR REVIEW OF PREMARKET NOTIFICATION REPORTS. (a) In General.—Subchapter A of chapter V is amended by adding at the end the following: “SEC. 523.ACCREDITED PERSONS. “(a) In General.— “(1) Review and classification of devices.—Not later than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under section 510(k) and making recommendations to the Secretary regarding the initial classification of devices under section 513(f)(1). “(2) Requirements regarding review.— “(A) In general.—In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation. “(B) Time period for review.—Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. “(C) Special rule.—The Secretary may change the initial classification under section 513(f)(1) that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under section 510(k) for the device, a statement explaining in detail the reasons for the change. “(3) Certain devices.— “(A) In general.—An accredited person may not be used to perform a review of— “(i) a class III device; “(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or “(iii) a class II device which requires clinical data in the report submitted under section 510(k) for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year. “(B) Adjustment.—In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 510(k) were not required to be submitted by reason of the operation of section 510(m). “(b) Accreditation.— 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 date of the enactment of the Food and Drug Administration 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 organization 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 and ethical business practices and shall agree in writing that as a minimum it will— “(i) certify that reported information accurately reflects data reviewed; 111 STAT. 2344 “(ii) limit work to that for which competence and capacity are available; “(iii) treat information received, records, reports, and recommendations as proprietary information; “(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and “(v) protect against the use, in carrying out subsection (a) with respect to a device, of any officer or employee of the person who has a financial conflict of interest regarding the device, and annually make available to the public disclosures of the extent to which the person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest. “(4) Selection of accredited persons.—The Secretary shall provide each person who chooses to use an accredited person to receive a section 510(k) report a panel of at least two or more accredited persons from which the regulated person may select one for a specific regulatory function. “(5) Compensation of accredited persons.—Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services. “(c) Duration.—The authority provided by this section terminates— “(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review at least 60 percent of the submissions under section 510(k), or “(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a determination described in paragraph (2)(B) of subsection (a) for at least 35 percent of the devices that are subject to review under paragraph (1) of such subsection, whichever occurs first.”. (b) Recordkeeping.—Section 704 (21 U.S.C. 374) is amended by adding at the end the following: “(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make recommendations of initial classifications of devices to the Secretary shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records. “(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited under section 523 for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.”. 111 STAT. 2345 (c) Conforming Amendment.—Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by adding at the end the following: “(y) In the case of a drug, device, or food— “(1) the submission of a report or recommendation by a person accredited under section 523 that is false or misleading in any material respect; “(2) the disclosure by a person accredited under section 523 of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or “(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this Act.”. (d) Reports on Program of Accreditation.— (1) Comptroller general.— (A) Implementation of program.—Not later than 5 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the extent to which the program of accreditation required by the amendment made by subsection (a) has been implemented. (B) Evaluation of program.—Not later than 6 months prior to the date on which, pursuant to subsection (c) of section 523 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the authority provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the use of accredited persons under such section 523, including an evaluation of the extent to which such use assisted the Secretary in carrying out the duties of the Secretary under such Act with respect to devices, and the extent to which such use promoted actions which are contrary to the purposes of such Act. (2) Inclusion of certain devices within program.—Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report providing a determination by the Secretary of whether, in the program of accreditation established pursuant to the amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act (relating to class II devices for which clinical data are required in reports under section 510(k)) should be removed.