Page:United States Statutes at Large Volume 90 Part 1.djvu/610
90 STAT. 560
PUBLIC LAW 94-295—MAY 28, 1976 BANNED DEVICES
"General Rule 21 USC 360f. Ante, p. 540.
"SEC. 516. (a) Whenever the Secretary finds, on the basis of all available data and information and after consultation with the appropriate panel or panels under section 513, that— "(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and "(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period; he may initiate a proceeding to promulgate a regulation to make such device a banned device. The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection. "Special Effective Date
Publication in Federal Register,
'** Notice and hearing.
"(b) The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and (2) before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as jjossible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, and either affirm, modify, or revoke such proposed regulation. "JUDICIAL REVIEW
"Application of Section 21 USC 360g.
Ante, p. 546.
Ante, p. 552.
517. (a) Not later than thirty days after— "(1) the promulgation of a regulation under section 513 classifying a device in class I or changing the classification of a device to class I or an order under subsection (f)(2) of such section reclassifying a device or denying a petition for reclassification of a device. "(2) the promulgation of a regulation under section 514 establishing, amending, or revoking a performance standard for a device, "(3) the issuance of an order under section 514(b) (2] or 515 (b)(2)(B) denying a request for reclassification of a device, "(4) the promulgation of a regulation under paragraph (3) of section 515(b) requiring a device to have an approval of a pre-