Page:United States Statutes at Large Volume 104 Part 6.djvu/136

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104 STAT. 4526 PUBLIC LAW 101-629—NOV. 28, 1990 report on the activities of the Office of International Relations under section 803 of the Federal Food, Drug, and Cosmetic Act, added by subsection (a). SEC. 16. REVIEW OF MARKET APPLICATIONS FOR ARTICLES COMPRISING COMBINATIONS OF DRUGS, DEVICES, AND BIOLOGICS. (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: "(fKD 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. Regulations. "(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).". flj) 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 componente, 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: