Page:United States Statutes at Large Volume 90 Part 1.djvu/593

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 543

"(4) The Secretary shall furnish each panel with adequate clerical and other necessary assistance. "Classification Panel Organization and Operation "(c)(1) The Secretary shall organize the panels according to the various fields of clinical medicine and fundamental sciences in which devices intended for human use are used. The Secretary shall refer a device to be classified under this section to an appropriate panel established or authorized to be used under subsection (b) for its review and for its recommendation respecting the classification of the device. The Secretary shall by regulation prescribe the procedure to be followed by the panels in making their reviews and recommendations. In making their reviews of devices, the panels, to the maximum extent practicable, shall provide an opportunity for interested persons to submit data and views on the classification of the devices. "(2)(A) Upon completion of a panel's review of a device referred to it under paragraph (1), the panel shall, subject to subparagraphs (B) and (C), submit to the Secretary'^ its recommendation for the classification of the device. Any such recommendation shall (i) contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and ( III) an identification of the risks to health (if any) presented by the device with respect to which the recommendation is made, and (ii) to the extent practicable, include a recommendation for the assignment of a priority for the application of the requirements of section 514 or 515 to a device recommended to be classified in class II or class III. "(B) A recommendation of a panel for the classification of a device in class I shall include a recommendation as to whether the device should be exempted from the requirements of section 510, 519, or 520(f). "(C) In the case of a device which has been referred under paragraph (1) to a panel, and which— "(i) is intended to be implanted in the human body or is purported or represented to be for a use in supporting or sustaining human life, and " ( i i)(I) has been introduced or delivered for introduction into interstate commerce for commercial distribution before the date of enactment of this section, or " ( II) is within a type of device which was so introduced or delivered before such date and is substantially equivalent to another device within that type, such panel shall reconmiend to the Secretary that the device be classified in class III unless the panel determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. If a panel does not recommend that sue]I a device be classified in class III, it shall in its recommendation to the Secretary for the classification of the device set forth the reasons for not recommending classification of the device in such class. "(3) The panels shall submit to the Secretary within one year of the date funds are first appropriated for the implementation of this section their recommendations respecting all devices of a type introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section.

89-194 0 _ 7 8 — n t 1

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Post, pp. 546, 552.

21 USC 360. ^^^ PP" ^ ^ '

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