Page:United States Statutes at Large Volume 111 Part 3.djvu/256

 Ill STAT. 2344 PUBLIC LAW 105-115—NOV. 21, 1997 "(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.— Tl ie 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.".

�