Page:United States Statutes at Large Volume 106 Part 1.djvu/271

 PUBLIC LAW 102-300—JUNE 16, 1992 106 STAT. 239 (1) IN GENERAL. —Section SOKqXD (21 U.S.C. 331(q)(l)) is amended— (A) by striking out "Or (B)" and inserting in lieu thereof (B) by inserting before the period a comma and "or (C) comply with a requirement under section 522". (2) MiSBRANDED DEVICES. — Section 502(t) (21 U.S.C. 352(t)) is amended— (A) by striking out "or (2)" and inserting in lieu thereof "(2r; and (B) by inserting before the period a comma and "or (3) to comply with a requirement under section 522". (b) APPROVAL. —Section 5220)) (21 U.S.C. 3601(b)) is amended— (1) by striking out "(a)" and inserting in lieu thereof "(a)(D*; (2) by inserting a comma after "commerce"; and (3) by adding after the first sentence the following: "Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.. SEC. 4. REPAIR, BEPLACEMENT, OR SEFUND. Section 518(b)(l)(A)(ii) (21 U.S.C. 360h(b)(l)(A)(ii)) is amended by striking out "and" each place it occurs and inserting in lieu tnereof"oi^. SEC. S. REPORTING. (a) AMENDMENTS.— Section 519 (21 U.S.C. 360i) is amended— (1) by redesignating paragraphs (1) through (6) of subsection (a) as paragraphs (4) through (9), respective^, tmd by inserting before paragraph (4) (as so redesignated) the following: "(1) shall require a device manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices— "(A) may have caused or contributed to a death or serious injuiy, or "(B) has malftmctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; "(2) shall define the term 'serious injury* to mean an injury that^ "(A) is life threatening, "(B) results in permanent impairment of a body function or permanent damage to a body structure, or (C) necessitates medical or surgical intervention to preclude permanent impairment of a Dody function or permanent damage to a body structure; "(3) shall require reporting of other significant adverse device experiences as determined by the Secretary to be necessary to be reported;"; and (2) in subsection (b)— (A) in paragraph (1), by striking out "there is a probability that a device has" each place it occurs and inserting in lieu thereof "a device has or may have"; (B) in paragraph (1KB)—

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