[Congressional Record Volume 169, Number 148 (Wednesday, September 13, 2023)]
[Senate]
[Page S4455]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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.
                                 ______