Page:United States Statutes at Large Volume 90 Part 1.djvu/592

 90 STAT. 542

Post, pp. 546, 552.

PUBLIC LAW 94-295—MAY 28, 1976 "(B) If the Secretary determines that there exists valid scientij&c evidence (other than evidence derived from investigations described in subparagraph (A)) — " (i) which is sufficient to determine the effectiveness of a device, and "(ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device, then, for purposes of this section and sections 514 and 515, the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence. "Classification; Classification Panels

"(b)(1) For purposes of— "(A) determining which devices intended for human use should be subject to the requirements of general controls, performance standards, or premarket approval, and "(B) providing notice to the manufacturers and importers of such devices to enable them to prepare for the application of such requirements to devices manufactured or imported by them, the Secretary shall classify all such devices (other than devices classified by subsection (f)) into the classes established by subsection (a). Panels of experts. For the purpose of securing recommendations with respect to the Establishment. classification of devices, the Secretary shall establish panels of experts or use panels of experts established before the date of the enactment of this section, or both. Section 14 of the Federal Advisory Commit5 USC app. I. tee Act shall not apply to the duration of a panel established under this paragraph. "(2) The Secretary shall appoint to each panel established under paragraph (1) persons who are qualified by training and experience ???; to evaluate the safety and effectiveness of the devices to be referred to the panel and who, to the extent feasible, possess skill in the use of, or experience in the development, manufacture, or utilization of, such devices. The Secretary shall make appointments to each panel so that each panel shall consist of members with adequately diversified expertise in such fields as clinical and administrative medicine, engineering, biological and physical sciences, and other related professions. In addition, each panel shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in the administration of this Act may be a member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof. " (3) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, but not at rates exceeding the daily equivalent of the rate in effect for grade GS-18 of the General Sched5 USC 5332 note, ule, for each day so engaged, including traveltime; and while so serving away from their homes or regular places of business each member may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently.

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