Sec. 513. Extended shelf life dates for essential devices
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The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506J ( 21 U.S.C. 356j ) the following: A manufacturer of a device subject to notification requirements under section 506J (in this section referred to as an essential device ) shall— submit to the Secretary data and information as required by subsection (b)(1); conduct and submit the results of any studies required under subsection (b)(3); and make any labeling change described in subsection
(c)by the date specified by the Secretary pursuant to such subsection. The Secretary may issue an order requiring the manufacturer of any essential device to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the device (including pilot, investigational, and final product validation) that are adequate to assess the shelf life of the device to determine the longest supported expiration date. If the data and information referred to in paragraph
(1)are not available or are insufficient, the Secretary may require the manufacturer of the device to— conduct studies adequate to provide the data and information; and submit to the Secretary the results, data, and information generated by such studies when available. The Secretary may issue an order requiring the manufacturer of an essential device to make by a specified date any labeling change regarding the expiration period that the Secretary determines to be appropriate based on the data and information required to be submitted under this section or any other data and information available to the Secretary. Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. . Section 303(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(f) ) is amended by adding at the end the following: If the manufacturer of a device subject to notification requirements under section 506J violates section 506K by failing to submit data and information as required under section 506K(b)(1), failing to conduct or submit the results of studies as required under section 506K(b)(3), or failing to make a labeling change as required under section 506K(c), such manufacturer shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation. . Subparagraph
(A)of section 564A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(a)(1)) is amended to read as follows: is approved or cleared under this chapter, otherwise listed as a device pursuant to section 510(j), conditionally approved under section 571, or licensed under section 351 of the Public Health Service Act; .
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- 21 USC 360bbb–3a(a)(1)
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Sec. 513
Extended shelf life dates for essential devices
Cite21 USC 360bbb–3a(a)(1)
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