; (2) 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— (A) 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; (B) validates such test prior to use; (C) notifies the Secretary of the assay validation; and (D) 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.