Page:United States Statutes at Large Volume 104 Part 6.djvu/134

 104 STAT. 4524 PUBLIC LAW 101-629—NOV. 28, 1990 "(3)(A) As part of a submission under section 510(k) respecting a device, the person required to file a premarket notification under such section shall provide an adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request by any person. Public "(B) Any summary under subparagraph (A) respecting a device information. shall Contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such device is substantially equivalent to another device.". 21 USC 360c 0>) REGULATIONS. —Within 12 months of the date of the enactment note. of this Act, the Secretary of Health and Human Services shall issue regulations establishing the requirements of the summaries under section 513(i)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a). SEC. 13. JUDICIAL REVIEW. Section 517(a) (21 U.S.C. 360g(a)) is amended— (1) by striking out "or" at the end of paragraph (6), and (2) by inserting after paragraph (7) the following new paragraphs: "(8) an order pursuant to section 513(i), "(9) a regulation under section 515(i)(2) or 520(1)(5)(B), or "(10) an order under section 520(c)(4)(B),". SEC. 14. HUMANITARIAN DEVICE EXEMPTION. (a) EXEMPTION.— Section 520 (21 U.S.C. 360j) is amended by adding at the end the following: "Humanitarian Device Exemption "(m)(l) To the extent consistent with the protection of the public health and safety and with ethical standards, it is the purpose of this subsection to encourage the discovery and use of devices intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States. "(2) The Secretary may grant a request for an exemption from the effectiveness requirements of sections 514 and 515 for a device for which the Secretary finds that— "(A) the device is designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States, "(B) the device would not be available to a person with a disease or condition referred to in subparagraph (A) unless the Secretary grants such an exemption and there is no comparable device, other than under this exemption, available to treat or diagnose such disease or condition, and "(C) the device will not expose patients to an unreasonable or signihcant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. "(3) No person granted an exemption under paragraph (2) with respect to a device may sell the device for an amount that exceeds

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