Suggested Amendments to H.R. 9984 (relating to Medical Devices) and Comparison of House and Senate Bills, Prepared by the Staff for ... , 93-2, March 1974
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accepted accordance Act as amended additional adequate advisory allow Amend Sec amended by Sec American application appoint appropriate approval Association assure Authorizes bill changes classification clinical committee conform court custom defect determines develop device Directs established evidence exempt existing experts Federal Register findings Government Group hazard Identical illness or injury initial insert intended interested persons labeling line 19 manufacturer means Medical methods notice notification offer offeror opportunity Page panel patients performance standard period permit persons phrase physician practicable premarket scientific review present President prior procedures professional promulgate proposed protocol provisions public health publish pursuant qualified reasonable Recommendation for Sec records reduce or eliminate referred regulations relating replace represented risk risk of illness Robert Rodney safety and effectiveness scientific review Secretary specifically submit substantial suggests testing tion unreasonable risk various trade associations
12 페이지 - Code. (2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the...
17 페이지 - ... substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling...
12 페이지 - In a case of actual controversy as to the validity of any order under section 103, any person who will be adversely affected by such order when it is effective may at any time prior to the sixtieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order.
12 페이지 - Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently.
12 페이지 - The judgment of the court affirming or setting aside, in whole or in part, any action of the Secretary 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, United States Code.
12 페이지 - A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in section 2112 of title 28, United States Code.
13 페이지 - Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.
12 페이지 - Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.
12 페이지 - The Secretary may modify his findings as to the facts, or make new findings, by reason of additional evidence so taken and filed, and...
12 페이지 - If the order of the Secretary refuses to issue, amend, or repeal a regula-tion and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secre-tary as to the facts, if supported by substantial evidence, shall be conclusive.