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1 device against any hazard to the public health probably

2 resulting from such use.

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"(2) As used in this subsection and subsection (f), 4 the term 'adequate scientific evidence' means evidence con5 sisting of sufficient well-controlled investigations, including 6 clinical investigations where appropriate, by experts quali7 fied by scientific training and experience to evaluate the ef8 fectiveness of the device involved, on the basis of which it 9 could fairly and responsibly be concluded by such experts 10 that the device will have the effect it purports or is repre11 sented to have under the conditions of use prescribed, recom12 mended, or suggested in the labeling or proposed labeling 13 thereof, unless the Secretary determines that other valid 14 scientific evidence is sufficient to establish the effectiveness of 15 the device.

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"(3) For the purposes of this section, when a device is 17 intended for use by a physician, surgeon, or other person 18 licensed or otherwise specially qualified therefor, its safety 19 and effectiveness shall be determined in the light of such 20 intended use.

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(4) (A) An applicant whose application has been de

22 nied approval (either pursuant to paragraph (3), or in consequence of the Secretary's finding pursuant to paragraph (2), of subsection (d)) may, by petition filed on or before the thirtieth day after the date upon which he receives no

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tice of such denial, obtain review thereof in accordance with subsection (i). The Secretary shall consider and give appro

3 priate weight to the report and recommendations received from the advisory committee conducting such review under such subsection.

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"(B) In lieu of the review provided by subparagraph (A), such applicant may, for good cause shown by such petition, obtain a hearing in accordance with section 554 of title 5 of the United States Code.

"Withdrawal of Approval

"(f) (1) The Secretary may, upon obtaining, where appropriate, advice on scientific matters from a panel or panels established pursuant to subsection (b), and after due

notice and opportunity for hearing to the applicant, issue an 15 order withdrawing approval of an application with respect to a device under this section if the Secretary finds

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“(A) (i) that clinical or other experience, tests, or other scientific data show that such device is unsafe for

use under the conditions of use upon the basis of which the application was approved; or (ii) on the basis of evidence of clinical experience, not included in or accompanying such application and not available to the Secretary until after the application was approved, or of tests by new methods or by methods not reasonably applicable when the application was approved, evaluated

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together with the evidence available to the Secretary

when the application was approved, that such device is not shown to be safe for use under the conditions of use on the basis of which the application was approved;

"(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 adequate scientific evidence that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

"(C) that the application filed pursuant to subsection (c) contains or was accompanied by an untrue statement of a material fact;

"(D) that the applicant has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation or order under subsection (a) of section 516, or that the applicant has refused to permit access to, or copying or vertification of, such records as required by paragraph

(2) of such subsection;

"(E) on the basis of new information before him,

evaluated together with the evidence before him when

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the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such device do not conform to the requirements of section 501 (g) and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary; or

"(F) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that the labeling of such device, based on a fair evaluation of all material facts,

is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary; or

"(G) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that such device is not

shown to conform in all respects to an applicable standard promulgated pursuant to section 513.

"(2) If the Secretary (or in his absence the officer 21 acting as Secretary) finds that an imminent health or safety 22 hazard is involved, he may by order suspend the approval of 23 such application immediately and give the applicant prompt 24 notice of his action and afford the applicant an opportunity 25 for an expedited hearing under this subsection. Such author

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1 ity to suspend the approval of an application may not be

2 delegated.

3 "(3) Any order under this subsection shall state the

4 findings upon which it is based.

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"Authority To Revoke Adverse Orders

"(g) Whenever the Secretary finds that the facts so 7 require, he shall revoke an order under subsection (e)

8 or (f) denying, withdrawing, or suspending approval of

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an application and shall approve such application or rein

state such approval, as may be appropriate.

"Service of Secretary's Orders

"(h) Orders of the Secretary under this section shall 13 be served (1) in person by any officer or employee of the 14 Department designated by the Secretary or (2) by mailing 15 the order by registered mail or certified mail addressed to the 16 applicant at his last known address in the records of the 17 Secretary.

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"Referral to Independent Advisory Committee

(i) (1) A person who has filed an application under 20 subsection (c) may petition the Secretary, in accordance 21 with subparagraph (A) of subsection (e) (4), to refer such 22 application, or the Secretary's action thereon, to an advisory 23 committee of experts for a report and recommendations with 24 respect to any question therein involved which requires the 25 exercise of scientific judgment. Upon such petition, or if the