DEVICE STANDARDS.

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 under this section, the Secretary shall, by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally 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 through publication of a notice in the Federal Register if the Secretary 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. 111 STAT. 2336 “(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). “(C) A person making a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of two years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.”. (b) Section 301.—Section 301 (21 U.S.C. 331) is amended by adding at the end the following: “(x) The falsification of a declaration of conformity submitted under section 514(c) or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section.”. (c) Section 501.—Section 501(e) (21 U.S.C. 351(e)) is amended— (1) by striking “(e)” and inserting “(e)(1)”; and (2) by inserting at the end the following: “(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.”. (d) Conforming Amendments.—Section 514(a) (21 U.S.C. 360d(a)) is amended— (1) in paragraph (1), in the second sentence, by striking “under this section” and inserting “under subsection (b)”; (2) in paragraph (2), in the matter preceding subparagraph (A), by striking “under this section” and inserting “under subsection (b)”; (3) in paragraph (3), by striking “under this section” and inserting “under subsection (b)”; and (4) in paragraph (4), in the matter preceding subparagraph (A), by striking “this section” and inserting “this subsection and subsection (b)”.