S.Amdt. 2600

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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