[Congressional Record Volume 166, Number 140 (Thursday, August 6, 2020)]
[Senate]
[Pages S5300-S5301]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2600. Mr. LEE submitted an amendment intended to be proposed to

[[Page S5301]]

amendment SA 2499 proposed by Mr. McConnell to the bill S. 178, to 
condemn gross human rights violations of ethnic Turkic Muslims in 
Xinjiang, and calling for an end to arbitrary detention, torture, and 
harassment of these communities inside and outside China; which was 
ordered to lie on the table; as follows:

        At the appropriate place, insert the following:

     SEC. __. STATE VALIDATION AND APPROVAL OF IN VITRO DIAGNOSTIC 
                   TESTS.

       (a) In General.--Notwithstanding any other provision of 
     law, including any provision of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) or section 353 of the 
     Public Health Service Act (42 U.S.C. 263a), a State may 
     validate and approve for use in the State an in vitro 
     diagnostic test (as defined in section 809.3 of title 21, 
     Code of Federal Regulations (or successor regulations)), for 
     use and distribution within the applicable State only, in 
     accordance with such processes and standards as the State may 
     require.
       (b) No Requirement to Notify FDA.--The manufacturer of an 
     in vitro diagnostic test validated and approved by a State 
     under subsection (a) shall not be required, with respect to 
     the use of such test in such State, to notify the Food and 
     Drug Administration, receive approval from the Food and Drug 
     Administration, or report results to the Food and Drug 
     Administration.
       (c) No Applicability of CLIA Requirement.--The requirements 
     of section 353 of the Public Health Service Act (42 U.S.C. 
     263a) shall not apply with respect to a test validated and 
     approved by a State, to the extent such test is used only 
     within that State.
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