Page:United States Statutes at Large Volume 90 Part 1.djvu/594

 90 STAT. 544

PUBLIC LAW 94-295—MAY 28, 1976 "Classification

Publication in "(d)(1) Upon receipt of a recommendation from a panel respecting Federal Register. ^ device, the Secretary shall publish in the Federal Eegister the panel's recommendation and a proposed regulation classifying such device and shall provide interested persons an opportunity to submit comments on such recommendation and the proposed regulation. After reviewing such comments, the Secretary shall, subject to paragraph (2), by regulation classify such device. "(2)(A) A regulation under paragraph (1) classifying a device in class I shall prescribe which, if any, of the requirements of section 21 USC 360. 510, 519, or 520(f) shall not apply to the device. A regulation which Post, pp. 564, makes a requirement of section 510, 519, or 520(f) inapplicable to a 565. device shall be accompanied by a statement of the reasons of the Secretary for making such requirement inapplicable. "(B) A device described in subsection (c)(2)(C) shall be classified in class III unless the Secretary determines that classification of the device in such class is not necessary to provide reasonable assurance ^ of its safety and effectiveness. A proposed regulation under paragraph (1) classifying such a device in a class other than class III shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for not classifying such device in such class and an identification of the risks to health (if any) presented by such device. "(3) In the case of devices classified in class II and devices classiPost, p. 552. fied under this subsection in class III and described in section 515(b) (1) the Secretary may establish priorities which, in his discretion, shall Post, p. 546. be used in applying sections 514 and 515, as appropriate, to such devices. "Classification Changes Regulation.

"(e) Based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation (1) change such device's classification, and (2) revoke, because of the change in classification, any regulation or requirement in Publication in effect under section 514 or 515 with respect to such device. In the Federal Register, promulgation of such a regulation respecting a device's classification, the Secretary may secure from the panel to which the device was last referred pursuant to subsection (c) a recommendation respecting the proposed change in the device's classification and shall publish in the Federal Register any recommendation submitted to the Secretary by the panel respecting such change. A regulation under this subsection chan^ng the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device. "Initial Classification of Certain Devices "(f)(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section is classified in class III unless— "(A) the device— "(i) is within a type of device (I) which was introduced or delivered for introduction into interstate commerce for commercial distribution before such date and which is to be classified pursuant to subsection (b), or (II) which was not so

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