S.Amdt. 1149

SA 1149. Mrs. BLACKBURN submitted an amendment intended to be
proposed by her to the bill H.R. 4366, making appropriations for
military construction, the Department of Veterans Affairs, and related
agencies for the fiscal year ending September 30, 2024, and for other
purposes; which was ordered to lie on the table; as follows:

At the appropriate place in title VII of division B, insert
the following:
Sec. 7__.  None of the funds made available to the Food and
Drug Administration by this Act may be used to issue final
guidance or a final rule that regulates laboratory-developed
tests as devices (as defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)) until the date
on which the Commissioner of Food and Drugs successfully
completes a voluntary pilot certification program of
excellence in vitro diagnostic validation under which the
Commissioner shall certify developers of in vitro diagnostic
tests if the developer meets criteria specified by the
Commissioner regarding the ability of the developer to ensure
the analytical and clinical validity of in vitro diagnostic
tests for a designated scope of testing methodologies and
techniques.
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