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Code · BILL · 115th Congress · H.R. 28 (Engrossed in House) — To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to adopt and implement a standard... · Sec. 2

Sec. 2. Identification and tracking of biological implants used in Department of Veterans Affairs medical facilities

700 words·~3 min read·/bill/115/hr/28/eh/section-2

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Subchapter II of chapter 73 of title 38, United States Code, is amended by adding at the end the following new section: The Secretary shall adopt the unique device identification system developed for medical devices by the Food and Drug Administration under section 519(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360i(f) ), or implement a comparable standard identification system, for use in identifying biological implants intended for use in medical procedures conducted in medical facilities of the Department.
In adopting or implementing a standard identification system for biological implants under paragraph (1), the Secretary shall permit a vendor to use any of the accredited entities identified by the Food and Drug Administration as an issuing agency pursuant to section 830.100 of title 21, Code of Federal Regulations, or any successor regulation. The Secretary shall implement a system for tracking the biological implants described in subsection
(a)from human donor or animal source to implantation. The tracking system implemented under paragraph
(1)shall be compatible with the identification system adopted or implemented under subsection (a). The Secretary shall implement inventory controls compatible with the tracking system implemented under paragraph
(1)so that all patients who have received, in a medical facility of the Department, a biological implant subject to a recall can be notified of the recall if, based on the evaluation by appropriate medical personnel of the Department of the risks and benefits, the Secretary determines such notification is appropriate. To the extent that a conflict arises between this section and a provision of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) or section 351 or 361 of the Public Health Service Act (42 U.S.C. 262 and 264) (including any regulations issued under such provisions), the provision of the Federal Food, Drug, and Cosmetic Act or Public Health Service Act (including any regulations issued under such provisions) shall apply. In this section, the term biological implant means any human cell, tissue, or cellular or tissue-based product or animal product— under the meaning given the term human cells, tissues, or cellular or tissue-based products in section 1271.3 of title 21, Code of Federal Regulations, or any successor regulation; or that is regulated as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) ). . The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 7330B the following new item: 7330C. Identification and tracking of biological implants. . The Secretary of Veterans Affairs shall adopt or implement the standard identification system for biological implants required by subsection
(a)of section 7330C of title 38, United States Code, as added by subsection (a), with respect to biological implants described in— subsection (d)(1) of such section, by not later than the date that is 180 days after the date of the enactment of this Act; and subsection (d)(2) of such section, in compliance with the compliance dates established by the Food and Drug Administration under section 519(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360i(f) ). The Secretary of Veterans Affairs shall implement the biological implant tracking system required by section 7330C(b) of title 38, United States Code, as added by subsection (a), by not later than the date that is 180 days after the date of the enactment of this Act. If the biological implant tracking system required by section 7330C(b) of title 38, United States Code, as added by subsection (a), is not operational by the date that is 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report explaining why the system is not operational for each month until such time as the system is operational. Each report submitted under paragraph
(1)shall include a description of the following: Each impediment to the implementation of the system described in such paragraph. Steps being taken to remediate each such impediment. Target dates for a solution to each such impediment.
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Sec. 2
Identification and tracking of biological implants used in Department of Veterans Affairs medical facilities
U.S.C.§ 360i
U.S.C.§ 301
U.S.C.§ 262
U.S.C.§ 321
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