graph (1)(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 "(II) on November 15, 1991, for devices not described in subclause (I). Effective date. "(ii) For each device described in clause (i)(I), the Secretary shall Federal publish a notice in the Federal Register setting forth the date, which Register, shall be not earlier than 1 year after the date of the notice, that data publication. 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 (D)(i)(II) 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)(1)(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 "(ii)(I) 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. Public information. 21 USC 360c note. "(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. "(B) Any summary under subparagraph (A) respecting a device 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.". (b) REGULATIONS.-Within 12 months of the date of the enactment 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) (1) 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 significant 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 the costs of research and development, fabrication, and distribution of the device. "(4) Devices granted an exemption under paragraph (2) may only be used "(A) in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and "(B) if, before the use of a device, an institutional review committee approves the use in the treatment or diagnosis of a disease or condition referred to in paragraph (2)(A). "(5) An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5year period. "(6) Within one year of the date of the enactment of this subsec- Regulations. tion, the Secretary shall issue regulations to implement this subsection.". 21 USC 360j note. 21 USC 360j (b) EFFECTIVE DATE.-Subsection (m) of section 520 of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection. (c) REPORT.-Within 4 years after the issuance of regulations under section 520(m)(6) of the Federal Food, Drug, and Cosmetic Act, note. as added by the amendment made by subsection (a), the Secretary of Health and Human Services shall report to the Congress (1) on the types of devices exempted under such section, (2) an evaluation of the effects of such section, and (3) a recommendation on extension of the section. SEC. 15. ESTABLISHMENT RELATIONS. OF THE OFFICE OF INTERNATIONAL (a) OFFICE.-Title VIII is amended by adding at the end the following: "OFFICE OF INTERNATIONAL RELATIONS "SEC. 803. (a) There is established in the Department of Health and Human Services an Office of International Relations. "(b) In carrying out the functions of the office under subsection (a), the Secretary may enter into agreements with foreign countries to facilitate commerce in devices between the United States and such countries consistent with the requirements of this Act. In such agreements, the Secretary shall encourage the mutual recognition of "(1) good manufacturing practice regulations promulgated under section 520(f), and "(2) other regulations and testing protocols as the Secretary determines to be appropriate." (b) REPORT.-Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall prepare and submit to the appropriate committees of Congress a 21 USC 383. 21 USC 383 note. Regulations. report on the activities of the Office of International Relations SEC. 16. REVIEW OF MARKET APPLICATIONS FOR ARTICLES COMPRISING (a) REVIEW.-Section 503 (21 U.S.C. 353) is amended (1) by striking out the section heading and inserting in lieu thereof the following: "EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND BIOLOGICAL PRODUCTS", and (2) by adding at the end the following: "(f)(1) The Secretary shall designate a component of the Food and Drug Administration to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of "(A) a drug (other than a biological product), the persons charged with premarket review of drugs shall have primary jurisdiction, "(B) a device, the persons charged with premarket review of devices shall have primary jurisdiction, or "(C) a biological product, the persons charged with premarket review of biological products shall have primary jurisdiction. "(2) Nothing in this subsection shall prevent the Secretary from using any agency resources of the Food and Drug Administration necessary to ensure adequate review of the safety, effectiveness, or substantial equivalence of an article. "(3) The Secretary shall promulgate regulations to implement market approval procedures in accordance with paragraphs (1) and (2) not later than 1 year after the date of enactment of this subsection. "(4) As used in this subsection: "(A) The term 'biological product' has the meaning given the term in section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)). "(B) The term 'market clearance' includes "(i) approval of an application under section 505, 507, 515, or 520(g), "(ii) a finding of substantial equivalence under this subchapter, and "(iii) approval of a product or establishment license under subsection (a) or (d) of section 351 of the Public Health Service Act (42 U.S.C. 262).". (b) DEFINITIONS.-Section 201 (21 U.S.C. 321) is amended (1) in paragraph (g)(1), by striking out "; but does not include devices or their components, parts, or accessories", and (2) in paragraph (h)(3), by striking out "any of its principal" and inserting in lieu thereof "its primary". SEC. 17. CIVIL PENALTIES. (a) AMENDMENT.-Section 303 (21 U.S.C. 333) is amended by adding at the end the following: "(f)(1)(A) Except as provided in subparagraph (B), any person who violates a requirement of this Act which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. "(B) Subparagraph (A) shall not apply "(i) to any person who violates the requirements of section 519(a) or 520(f) unless such violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk to public health, "(ii) to any person who commits minor violations of section 519(e) or 519(f) (only with respect to correction reports) if such person demonstrates substantial compliance with such section, or “(iii) to violations of section 501(a)(2)(A) which involve one or more devices which are not defective. "(2)(A) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after opportunity for a hearing provided in accordance with this subparagraph and section 554 of title 5, United States Code. Before issuing such an order, the Secretary shall give written notice to the person to be assessed a civil penalty under such order of the Secretary's proposal to issue such order and provide such person an opportunity for a hearing on the order. In the course of any investigation, the Secretary may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. "(B) In determining the amount of a civil penalty, the Secretary shall take into account the nature, circumstances, extent, and gravity of the violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require. "(C) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally determined, or the amount agreed upon in compromise, may be deducted from any sums owing by the United States to the person charged. "(3) Any person who requested, in accordance with paragraph (2)(A), a hearing respecting the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty may file a petition for judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessment was issued. "(4) If any person fails to pay an assessment of a civil penalty"(A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (3), or "(B) after a court in an action brought under paragraph (3) has entered a final judgment in favor of the Secretary, the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (3) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, |