; and (2) in subsection (d)— (A) by striking Terms.— The terms and inserting the following: Terms.— In this section: (1) Health insurance terms The terms ; and (B) by adding at the end the following: (2) Qualified in vitro diagnostic product (A) The term qualified in vitro diagnostic product means an in vitro diagnostic product (as defined in section 809.3(a) of title 21, Code of Federal Regulations) for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 that is 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, and 360bbb–3). (B) Such term includes an in vitro diagnostic test that— (i) subject to subparagraph (C), is developed and used in a laboratory certified to perform high-complexity testing pursuant to section 353 of the Public Health Service Act ( 42 U.S.C. 263a ) and with respect to which such laboratory— (I) validates prior to use for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, including by obtaining confirmation of validation using an assay authorized under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ); (II) notifies the Secretary of such use; and (III) includes a statement together with the results of the test that reads: This test has not been FDA cleared or approved. This test has been authorized by FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens