Page:United States Statutes at Large Volume 90 Part 1.djvu/605

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 555

"(A) there is a lack of a showing of reasonable assurance that such device is safe under the conditions of use prescribed, recom\5r mended, or suggested in the proposed labeling thereof; " (B) there is a lack of a showing of reasonable assurance that the device is effective under the conditions of use prescribed, rec' ommended, or suggested in the proposed labeling thereof; "(C) the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or installation of such device do not conform to the requirements of section 520(f); Post, p. 565. "(D) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or " (E) such device is not shown to conform in all respects to a performance standard in effect under section 514 compliance with ^f^te, p. 546. which is a condition to approval of the application and there is a lack of adequate information to justify the deviation from such - »; / standard. Any denial of an application shall, insofar as the Secretary deter- Statement. mines to be practicable, be accompanied by a statement informing the applicant of the measures required to place such application in approvable form (which measures may include further research by the applicant in accordance with one or more protocols prescribed by the Secretary). "(3) An applicant whose application has been denied approval may, Review. by petition filed on or before the thirtieth day after the date upon which he receives notice of such denial, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g), and any interested person may obtain review, in accordance with paragraph (1) or (2) of subsection (g), of an order of the Secretary approving an application. "Withdrawal of Approval of Application "(e)(1) The Secretary shall, upon obtaining, where appropriate, Notice and advice on scientific matters from a panel or panels under section 613, hearing. and after due notice and opportunity for informal hearing to the Ante, p. 540. holder of an approved application for a device, issue an order withdrawing approval of the application if the Secretary finds— "(A) that such device is unsafe or ineffective under the condi*1KI. 'Ms* tions of use prescribed, recommended, or suggested in the labeling thereof; "(B) on the basis of new information before him with respect to such device, evaluated together with the evidence available to him when the application was approved, that there is a lack of a showing of reasonable assurance that the device is safe or effective under the conditions of use prescribed, recommended, or suggested in the labeling thereof; "(C) that the application contained or was accompanied by an untrue statement of a material fact; "(D) that the applicant (i) has failed to establish a system Record for maintaining records, or has repeatedly or deliberately failed maintenance. to maintain records or to make reports, required by an applicable regulation under section 519(a), (ii) has refused to permit access Post, p. 564, to, or copying or verification of, such records as required by section 704, or (iii) has not complied with the requirements of 21 USC 374. 21 USC 360. section 510; " (E) on the basis of new information before him with respect to such device, evaluated together with the evidence before him when the application was approved, that the methods used in, or

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