Page:United States Statutes at Large Volume 111 Part 3.djvu/261

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'. ';iX-?^'.'j PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2349 (8) a safe and effective noninvasive blood glucose meter would likely improve control and management of diabetes by increasing the number of tests conducted by people with diabetes, particularly children; and (9) the Food and Drug Administration is responsible for reviewing all applications for new medical devices in the United States. (b) SENSE OF CONGRESS.— I t is the sense of the Congress that the availability of a safe, effective, noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes across America and the world. SEC. 216. USE OF DATA RELATING TO PREMARKET APPROVAL; PROD- UCT DEVELOPMENT PROTOCOL. (a) USE OF DATA RELATING TO PREMARKET APPROVAL. — (1) IN GENERAL. —Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: "(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition and other trade secrets) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in— "(i) approving another device; "(ii) determining whether a product development protocol has been completed, under section 515 for another device; "(iii) establishing a performance standard or special control under this Act; or "(iv) classifying or reclassifying £mother device under section 513 and subsection (1)(2). "(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency actions described in subparagraph (A).". (2) CONFORMING AMENDMENTS. —Section 517(a) (21 U.S.C. 360g(a)) is amended— (A) in paragraph (8), by adding "or" at the end; (B) in paragraph (9), by striking ", or" and inserting a comma; and (C) by striking paragraph (10). (b) PRODUCT DEVELOPMENT PROTOCOL.— Section 515(f)(2) (21 U.S.C. 360e(f)(2)) is amended by striking "he shall" and all that follows and inserting the following: "the Secretary— "(A) may, at the initiative of the Secretary, refer the proposed protocol to the appropriate panel under section 513 for its recommendation respecting approval of the protocol; or "(B) shall so refer such protocol upon the request of the submitter, unless the Secretary finds that the proposed protocol and accompanying data which would be reviewed by such panel substantially duplicate a product development protocol and accompanying data which have previously been reviewed by such a panel.".