Page:United States Statutes at Large Volume 90 Part 1.djvu/596

 90 STAT. 546

21 USC 360. Post, pp. 564,

PUBLIC LAW 94-295—MAY 28, 1976 tion (d) (relating to publication of recommendations, opportunity for submission of comments, and exemption from sections 510, 519, and 520(f)) shall apply with respect to action by the Secretary on petitions submitted under subparagraph (A),

565.

"Information " (g) Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device. "Definitions "(h) For purposes of this section and sections 501, 510, 514, 515, 21 USC 351,360. 516, 519, and 520— Post, pp. 552, "(1) a reference to 'general controls' is a reference to the con5^trols authorized by or under sections 501, 502, 510, 516, 518, 519, and 520, "(2) a reference to'class IVclass II ', or'class II P is a reference to a class of medical devices described in subparagraph (A), (B), or (C) of subsection (a)(1), and Ante, p. 540. "(3) a reference to a 'panel under section 513' is a reference to a panel established or authorized to be used under this section. "PERFORMANCE STANDARDS

"Provisions of Standards Regulation. 21 USC 360d.

Testing.

"SEC. 514. (a)(1) The Secretary may by regulation, promulgated in accordance with this section, establish a performance standard for a class II device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under this section if the device has been reclassified as a class II device under a regulation under section 513(e) but such regulation provides that the reclassification is not to take effect until the effective date of such a standard for the device. "(2) A performance standard established under this section for a device— " (A) shall include provisions to provide reasonable assurance of its safe and effective performance; "(B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include— "(i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections 'to such systems, "(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for the testing (on a sample basis or, if necessary, on an individual basis) by the Secretary or by another person at the direction of the Secretary, "(iii) jjrovisions for the measurement of the performance characteristics of the device, "(iv) provisions requiring that the results of each or of certain of the tests of the device required to be made under

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