S.Amdt. 2144

SA 2144. Mr. HATCH (for himself, Mr. Burr, Mr. Alexander, and Mr. Roberts) submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:

On page 150, between lines 2 and 3, insert the following:

“(C)(i) Reclassification by administrative order under subparagraph (A) shall apply only in the case of reclassification of a class III or class II device as a class II or class I device. The Secretary may reclassify a class I or class II device as a class II or class III device by regulation and revoke, because of the change in classification, any regulation or requirement in effect under section 514 or 515 with respect to such device. In the promulgation of such a regulation respecting a device's classification, the Secretary may secure from the panel to which the device was last referred pursuant to subsection (c) a recommendation respecting the proposed change in the device's classification and shall publish in the Federal Register any recommendation submitted to the Secretary by the panel respecting such change. A regulation under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device.

“(ii) In the case of a device reclassified as described in clause (i), paragraph (2), section 514(a)(1), and section 517(a)(1) shall apply to a regulation promulgated under clause (i) in the same manner such provisions apply to an order issued under subparagraph (A).”.