Sec. 542. Centralized testing information website
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The Secretary shall establish and maintain a public, searchable webpage, to be updated and corrected as necessary through a process established by the Secretary, on the website of the Department of Health and Human Services that— identifies all in vitro diagnostic and serological tests used in the United States to analyze clinical specimens for detection of SARS–CoV–2 or antibodies specific to SARS–CoV–2, including— those tests— that are approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) , 360c, 360e, 360bbb–3); that have been validated by the test’s developers for use on clinical specimens and for which the developer has notified the Food and Drug Administration of the developer’s intent to market the test consistent with applicable guidance issued by the Secretary; or that have been developed and authorized by a State that has notified the Secretary of the State’s intention to review tests intended to diagnose COVID–19; and other SARS–CoV–2-related tests that the Secretary determines appropriate in guidance, which may include tests related to the monitoring of COVID–19 patient status; provides relevant information, as determined by the Secretary, on each test identified pursuant to paragraph (1), which may include— the name and contact information of the developer of the test; the date of receipt of notification by the Food and Drug Administration of the developer’s intent to market the test; the date of authorization for use of the test on clinical specimens, where applicable; the letter of authorization for use of the test on clinical specimens, where applicable; any fact sheets, manufacturer instructions, and package inserts for the test, including information on intended use; sensitivity and specificity of the test; and in the case of tests distributed by commercial manufacturers, the number of tests distributed and, if available, the number of laboratories in the United States with the required platforms installed to perform the test; and includes— a list of laboratories certified under section 353 of the Public Health Service Act ( 42 U.S.C. 263a ; commonly referred to as CLIA ) that— meet the regulatory requirements under such section to perform high- or moderate-complexity testing; and are authorized to perform SARS–CoV–2 diagnostic or serological tests on clinical specimens; and information on each laboratory identified pursuant to subparagraph (A), including— the name and address of the laboratory; the CLIA certificate number; the laboratory type; the certificate type; and the complexity level.
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