Page:United States Statutes at Large Volume 116 Part 2.djvu/837

 PUBLIC LAW 107-250—OCT. 26, 2002 116 STAT. 1619 "(iv) Proposed labels, labeling, and advertising sufficient to describe the device, its intended use, and directions for use. "(v) Full reports of all information, published or known to or which should be reasonably known to the applicant, concerning investigations which have been made to show whether or not the device is safe or effective. "(vi) A description of the device's components, ingredients, and properties. "(vii) A full description of the methods used in, and the facilities and controls used for, the reprocessing and packing of the device. "(viii) Such samples of the device that the Secretary may reasonably require. "(ix) A financial certification or disclosure statement or both, as required by part 54 of title 21, Code of Federal Regulations. "(x) A statement that the applicant believes to the best of the applicant's knowledge that all data and information submitted to the Secretary are truthful and accurate and that no material fact has been omitted in the report. "(xi) Any additional data and information, including information of the type required in paragraph (1) for an application under such paragraph, that the Secretary determines is necessary to determine whether there is reasonable assurance of safety and effectiveness for the reprocessed device. "(xii) Validation data described in section 510(o)(l)(A) that demonstrates that the reasonable assurance of the safety or effectiveness of the device will remain after the maximum number of times the device is reprocessed as intended by the person submitting such report. "(B) In the case of a class III device referred to in subsection (a) that is a reprocessed single-use device: "(i) Subparagraph (A) of this paragraph applies in lieu of paragraph (1). "(ii) Subject to clause (i), the provisions of this section apply to a report under subparagraph (A) to the same extent and in the same manner as such provisions apply to an application under paragraph (1). "(iii) Each reference in other sections of this Act to an application under this section, other than such a reference in section 737 or 738, shall be considered to be a reference to a report under subparagraph (A). "(iv) Each reference in other sections of this Act to a device for which an application under this section has been approved, or has been denied, suspended, or withdrawn, other than such a reference in section 737 or 738, shall be considered to be a reference to a device for which a report under subparagraph (A) has been approved, or has been denied, suspended, or withdrawn, respectively.". (d) DEFINITIONS.— Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: "(11)(1) The term 'single-use device' means a device that is intended for one use, or on a single patient during a single procedure.

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