Page:United States Statutes at Large Volume 104 Part 6.djvu/131

This page needs to be proofread.


PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4521 "(I) not include recall of a device from individuals, and "(II) not include recall of a device from device user facilities if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, and "(ii) shall provide for notice to individuals subject to the risks associated with the use of such device. In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 705(b). "(3) The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c).". SEC. 9. TEMPORARY SUSPENSION OF APPROVAL OF APPLICATION. (a) SUSPENSION.— Section 515(e) (21 U.S.C. 360e(e)) is amended— (1) by adding at the end the following: "(3) If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a device under an approved application would cause serious, adverse health consequences or death, the Secretary shall by order temporarily suspend the approval of the application approved under this section. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.", and (2) in the subsection heading, by inserting "and Temporary Suspension" after "Withdrawal". (b) CONFORMING AMENDMENT. —Section 501(f) (21 U.S.C. 351(f) is amended— (1) in subpar^aph (A)(iiXII), by striking out "or withdrawn" and inserting in lieu thereof, suspended, or withdrawn", (2) in subparagraph (B)(ii), by striking out "which does not have such an application in effect" and inserting in lieu thereof "which has an application which has been suspended or is otherwise not in effect", and (3) in subparagraph (C), by striking out "which does not have such an application in effect" and inserting in lieu thereof "which has an application which has been suspended or is otherwise not in effect". SEC. 10. POSTMARKET SURVEILLANCE. Subchapter A of chapter 5 is amended by inserting after section 521 (21 U.S.C. 360k) the following new section: "POSTMARKET SURVEILLANCE "SEC. 522. (a) IN GENERAL.— 21 USC 360/. "(1) REQUIRED SURVEILLANCE. — The Secretary shall require a manufacturer to conduct postmarket surveillance for any device of the manufacturer first introduced or delivered for introduction into interstate commerce after January 1, 1991, that— "(A) is a permanent implant the failure of which may cause serious, adverse health consequences or death, "(B) is intended for a use in supporting or sustaining human life, or