Page:United States Statutes at Large Volume 104 Part 6.djvu/130

 104 STAT. 4520 PUBLIC LAW 101-629—NOV. 28, 1990 SEC. 7. REPORTS OF REMOVALS AND CORRECTIONS. Section 519 (21 U.S.C. 360i), as amended by sections 2 and 3, is amended by adding at the end the following: "Reports of Removals and Corrections "(fKD Except as provided in paragraph (2), the Secretary shall by regulation require a manufacturer, importer, or distributor of a device to report promptly to the Secretary any correction or removal of a device undertaken by such manufacturer, importer, or distributor if the removal or correction was undertaken— "(A) to reduce a risk to health posed by the device, or "(B) to remedy a violation of this Act caused by the device which may present a risk to health. A manufacturer, importer, or distributor of a device who undertakes a correction or removal of a device which is not required to be reported under this paragraph shall keep a record of such correction or removal. "(2) No report of the corrective action or removal of a device may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a). "(3) For purposes of paragraphs (1) and (2), the terms 'correction' and 'removal' do not include routine servicing.". SEC. 8. RECALL AUTHORITY. Section 518 (21 U.S.C. 360h).is amended by adding at the end the following new subsection: "Recall Authority "(e)(1) If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)— "(A) to immediately cease distribution of such device, and "(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such device. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. "(2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the device with respect to which the order was issued, the Secretary shall, except as provided in Reports. subparagraphs (B) and (C), amend the order to require a recall. The Secretary shall specify a timetable in which the device recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. "(B) An amended order under subparagraph (A)— "(i) shall—

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