Page:United States Statutes at Large Volume 90 Part 1.djvu/612

 90 STAT. 562

PUBLIC LAW 94-295—MAY 28, 1976 "Finality of Judgments

Review.

"(d) The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28 of the United States Code. "Other Remedies "(e) The remedies provided for in this section shall be in addition to and not in lien of any other remedies provided by law. "Statement of Reasons "(f) To facilitate judicial review under this section or under any other provision of law of a regulation or order issued under section 513, 514, 515, 516, 518, 519, 520, or 521 each such regulation or order shall contain a statement of the reasons for its issuance and the basis, in the record of the proceedings held in connection with its issuance, for its issuance. "NOTIFICATION AND OTHER REMEDIES

"Notification 21 USC 360h.

"SEC. 518. (a) If the Secretary determines that— "(1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and "(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this Act (other than this section) to eliminate such risk, the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notification. If the Secretary makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the device provide for the notification of the individuals whom the health professionals treated with the device of the risk presented by the device and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order. "Repair, Replacement, or Refund

Hearing.

"(b)(1)(A) If, after affording opportunity for an informal hearing, the Secretary determines that— "(i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commer-

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