Sec. 4141. Emergency use of laboratory developed tests
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For the time in which the public health emergency under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ) related to the coronavirus (COVID-19), declared by the Secretary of Health and Human Services (referred to in this section as the Secretary ) on January 31, 2020, is in place (or such other period of time determined by the Secretary), tests intended to diagnose COVID–19 that are described in subsection
(b)may be lawfully marketed in accordance with this section. Tests described in subsection
(a)may be lawfully marketed, during the period described in such subsection, if such test— is developed in a State that has notified the Secretary of its intention to review tests intended to diagnose COVID-19; is developed in a laboratory with a certificate to conduct high-complexity testing pursuant to section 353 of the Public Health Service Act ( 42 U.S.C. 263a ), and the developer of such test— is pursuing an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) and provides updates to the Secretary on efforts to pursue such authorization; validates such test prior to use; notifies the Secretary of the assay validation; and includes a statement together with the results of the test that reads: This test was developed for use as a part of a response to the public health emergency declared to address the outbreak of COVID-19. This test has not been reviewed by the Food and Drug Administration. ; or is an in vitro diagnostic test for which the developer of such test meets all of the requirements of subparagraphs
(A)through
(D)of paragraph
(2)with respect to the test. Notwithstanding the termination of a declaration under subsection
(b)of section 564 of the Federal Food, Drug, and Cosmetic Act, or a revocation under subsection
(g)of such section with respect to a product described in subsection (a), the Secretary shall consult with the developer of such in vitro diagnostic test with respect to the appropriate disposition of such test to ensure that authorization of any in vitro diagnostic test under this section shall continue to be effective to provide for continued use of such product to prevent or detect COVID–19. In this section, the term in vitro diagnostic test has the meaning given the term in vitro diagnostic product in section 809.3(a) of title 21, Code of Federal Regulations (or successor regulations).
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- 21 USC 360bbb–3
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