Page:United States Statutes at Large Volume 90 Part 1.djvu/591

 PUBLIC LAW 94-295~MAY 28, 1976 of substantial importance in preventing impairment of human health, and " (II) does not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i). "(B) CLASS II, PERFORMANCE STANDARDS.—A device which cannot be classified as a class I device because the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance, and for which it is therefore necessary to establish for the device a performance standard under section 514 to provide reasonable assurance of its safety and effectiveness. "(C) CLASS III, PREMARKET APPROVAL.—A device which because— "(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness, and " ( i i)(I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or " ( II) presents a potential unreasonable risk of illness or injury, is to be subject, in accordance with section 515, to premarket approval to provide reasonable assurance of its safety and effectiveness. If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information. "(2) For purposes of this section and sections 514 and 515, the safety and effectiveness of a device are to be determined— "(A) with respect to the persons for whose use the device is represented or intended, "(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and "(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. "(3)(A) Except as authorized by subparagraph (B), the effectiveness of a device is, for purposes of this section and sections 514 and 515, to be determined, in accordance with regulations promulgated by the Secretary, on the basis of well-controlled investigations, including clinical investigations where appropriate, by experts qualified by training and experience to evaluate the effectiveness of the device, from which investigations 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.

90 STAT. 541

21 USC 351,352, 360. ^^l*'?L ^c2'c * ' ' Post, p. 546.

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Post, p. 552.

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