Page:United States Statutes at Large Volume 104 Part 6.djvu/133

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PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4523 Effective date. Federal Register, publication. graph (I)(A) shall be available for use by the Secretary as the evidentiary basis for the regulatory action described in subparagraph (A). "(D)(i) This paragraph shall become effective— "(I) on November 15, 1990, for devices for which four devices of a kind were approved on or before December 31, 1987, and "(11) on November 15, 1991, for devices not described in subclause (I). "(ii) For each device described in clause (i)(D, the Secretary shall publish a notice in the Federal Register setting forth the date, which shall be not earlier than 1 year after the date of the notice, that data identified in subparagraph (A) shall be available for the use of the Secretary. "(E)(i) Except as provided in clause (ii), the approval date of a device, for purposes of this paragraph, shall be the date of the letter of the Secretary to the applicant approving a device under section 515 and permitting the applicant to commercially distribute the device. "(ii) For each device described in subparagraph (DXDdD for which the original application for a fourth device of a kind is approved by the Secretary before November 1, 1991, the approval date of the fourth device of a kind shall be deemed to be November 15, 1991. "(F) Any challenge to an order under subparagraph (B) shall be made not later than 30 days after the date of the Federal Register notice referred to in such subparagraph.". SEC. 12. SUBSTANTIAL EQUIVALENCE. (a) SUBSTANTIAL EQUIVALENCE.—Section 513 (21 U.S.C. 360j) is 21 USC 360c. amended by adding at the end the following new subsection: "Substantial Equivalence "(i)(l)(A) For purposes of determinations of substantial equivalence under subsection (f) and section 520(1), the term 'substantially equivalent' or 'substantial equivalence' means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device— "(i) has the same technological characteristics as the predicate device, or "(iiXD has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device. "(B) For purposes of subparagraph (A), the term 'different technological characteristics' means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device. "(2) A device may not be found to be substantially equivalent to a - predicate device that has been removed from the market at the initiative of the Secretary or that has been determined to be misbranded or adulterated by a judicial order.