Page:United States Statutes at Large Volume 111 Part 3.djvu/247

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2335 "In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use."; (3) by amending paragraph (5) to read as follows: "(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met."; and (4) by amending paragraph (6) to read as follows: "(6) The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.". SEC. 204. DEVICE STANDARDS. (a) ALTERNATIVE PROCEDURE.— Section 514 (21 U.S.C. 360d) is amended by adding at the end the following: "Recognition of a Standard "(c)(1)(A) In addition to establishing a performance standard Federal Register, under this section, the Secretary shall, by publication in the Federal publication. Register, recognize all or part of an appropriate standard established by a nationally or internationaly recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act to which such standard is applicable. "(B) If a person elects to use a standard recognized by the Secretary under subparagraph (A) to meet the requirements described in such subparagraph, the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to meet any requirement regarding devices under this Act. "(2) The Secretary may withdraw such recognition of a standard Federal Register, through publication of a notice in the Federal Register if the Sec- publication, retary determines that the standard is no longer appropriate for meeting a requirement regarding devices under this Act. "(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds— "(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or "(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review.

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