Page:United States Statutes at Large Volume 90 Part 1.djvu/603

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 553

" (B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type, the Secretary shall by regulation, promulgated in accordance with this subsection, require that such device have an approval under this section of an application for premarket approval. "(2)(A) A proceeding for the promulgation of a regulation under Publication in paragraph (1) respecting a device shall be initiated by the publica- Federal Register. tion in the Federal Kegister of a notice of proposed rulemaking. Such notice shall contain— " (i) the proposed regulation; "(ii) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved application for premarket approval and the benefit to the public from use of the device; "(iii) opportunity for the submission of comments on the proposed regulation and the proposed findings; and "(iv) opportunity to request a change in the classification of the device based on new information relevant to the classification of the device. "(B) If, within fifteen days after publication of a notice under sub- Publication in paragraph (A), the Secretary receives a request for a change in the Federal Register. classification of a device, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 513, by order published in the Federal Register, either deny the Ante, p. 540. request for change in classification or give notice of his intent to initiate such a change under section 513(e). "(3) After the expiration of the period for comment on a proposed Publication in regulation and proposed findings published under paragraph (2) Federal Register. and after consideration of comments submitted on such proposed regulation and findings, the Secretary shall (A) promulgate such regulation and publish in the Federal Register findings on the matters referred to in paragraph (2)(A) (ii), or (B) publish a notice terminating the proceeding for the promulgation of the regulation together t with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 516) initiate a proceeding Post, p. 560. under section 513(e) to reclassify the device subject to the proceeding terminated by such notice. "(4) The Secretary, upon his own initiative or upon petition of an interested person, may by regulation amend or revoke any regulation promulgated under this subsection. A regulation to amend or revoke a regulation under this subsection shall be promulgated in accordance with the requirements prescribed by this subsection for the promulgation of the regulation to be amended or revoked. "Application for Premarket Approval "(c)(1) Any person may file with the Secretary an application for premarket approval for a class III device. Such an application for a device shall contain— "(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective; "(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;

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