Page:United States Statutes at Large Volume 116 Part 2.djvu/836

 116 STAT. 1618 PUBLIC LAW 107-250—OCT. 26, 2002 "(B) For each device or type of device included on the list under subparagraph (A), a report under subsection (k) shall be submitted to the Secretary not later than 15 months after the publication of the initial list, or a revision of the list, whichever terminates the exemption for the device. During such 15-month period, the Secretary may not take any action under this Act against such device solely on the basis that such report has not been submitted to the Secretary. After the submission of the report to the Secretary the Secretary may not determine that the device is misbranded under section 502(o), adulterated under section 501(f)(1)(B), or take action against the device under section 301(p) for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission; (ii) the Secretary determines by order that the device is substantially equivalent to a pre(Ucate device; or (iii) the Secretary determines by order that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, the device can no longer be legally marketed. Deadlines. "(C) In the case of semi-critical devices, the initial list under subparagraph (A) shall be published not later than 18 months after the effective date of this subsection. In the case of critical devices, the initial list under such subparagraph shall be published not later than six months after such effective date. "(D) Section 502(o) applies with respect to the failure to submit a report under subsection (k) that is required pursuant to subparagraph (A), including a failure of the report to include validation data required in such subparagraph. "(E) The termination under subparagraph (A) of an exemption under subsection (1) or (m) for a critical or semicritical reprocessed single-use device does not terminate the exemption under subsection (1) or (m) for the original device.". (c) PREMARKET REPORT. —Section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended— (1) in subsection (a), in the matter after and below paragraph (2), by inserting before the period the following: "or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval"; and (2) in subsection (c)— (A) by redesignating paragraph (2) as paragraph (3); and (B) by inserting after paragraph (1) the following paragraph: "(2)(A) Any person may file with the Secretary a report seeking premarket approval for a class III device referred to in subsection (a) that is a reprocessed single-use device. Such a report shall contain the following: "(i) The device name, including both the trade or proprietary name and the common or usual name. "(ii) The establishment registration number of the owner or operator submitting the report. "(iii) Actions taken to comply with performance standards under section 514.

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