Page:United States Statutes at Large Volume 104 Part 6.djvu/124

 104 STAT. 4514 PUBLIC LAW 101-629—NOV. 28, 1990 (1) Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out "and" at the end of paragraph (4), by striking out the period at the end of paragraph (5) and inserting in lieu thereof "; and", and by adding after paragraph (5) the following: "(6) shall require distributors who submit such reports to submit copies of the reports to the manufacturer of the device for which the report was made.". Effective date. (2) Section 519(a)(6), as added by the amendment made by 21 USC 360i paragraph (1), shall take effect upon the effective date of final regulations under subsection (c). (b) CERTIFICATION, DEVICE TRACKING.— (1) Section 519 (21 U.S.C. 360i), as amended by section 2, is amended by adding at the end the following: "Certification "(d) Each manufacturer, importer, and distributor required to make reports under subsection (a) shall submit to the Secretary annually a statement certifying that— "(1) the manufacturer, importer, or distributor did file a certain number of such reports, or "(2) the manufacturer, importer, or distributor did not file any report under subsection (a). "Device Tracking "(e) Every person who registers under section 510 and is engaged in the manufacture of— "(1) a device the failure of which would be reasonably likely to have serious adverse health consequences and which is (A) a permanently implantable device, or (B) a life sustaining or life supporting device used outside a device user facility, or "(2) any other device which the Secretary may designate, shall adopt a method of device tracking.". (2) Section 520(j) (21 U.S.C. 360j(j)) is amended by striking out "No" and inserting in lieu thereof "Except as provided in section 519(e), no". Effective (3) Section 519(e), as added by the amendment made by 9?*fTGr- Qcnparagraph (1), shall take effect upon the effective date of final note regulations under subsection (c). 21 USC 360i (c) REGULATIONS.— note. (1)(A) Not later than 9 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations— Records. (i) to require distributors of devices to establish and maintain records and to make reports (including reports required by part 803 of title 21 of the Code of Federal Regulations) under section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act, and (ii) to implement section 519(e) of such Act. The Secretary may exempt from regulations described in clause (i) classes of distributors of class I and class II devices from whom reports are not necessary for the protection of the public health. (B) Regulations under subparagraph (A) shall—

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