[Congressional Record Volume 167, Number 41 (Thursday, March 4, 2021)]
[Senate]
[Page S1197]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 926. Mr. MARSHALL submitted an amendment intended to be proposed 
to amendment SA 891 proposed by Mr. Schumer to the bill H.R. 1319, to 
provide for reconciliation pursuant to title II of S. Con. Res. 5; 
which was ordered to lie on the table; as follows:
       At the end of title II, insert the following:

                Subtitle M--Food and Drug Administration

     SEC. 2931. USING EMERGENCY USE AUTHORIZATION DATA AND REAL 
                   WORLD EVIDENCE GATHERED DURING AN EMERGENCY TO 
                   SUPPORT DRUG, BIOLOGICAL PRODUCT, AND PREMARKET 
                   DEVICE APPLICATIONS.

       (a) In General.--Data generated to support an authorization 
     under section 564 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bbb-3) with respect to a drug, biological 
     product, or device, and real world evidence relating to such 
     drug, biological product, or device used pursuant to such 
     authorization, may constitute valid scientific evidence, and 
     shall be considered for purposes of--
       (1) reviewing submissions pursuant to section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 
     section 351 of the Public Health Service Act (42 U.S.C. 262);
       (2) reviewing submissions pursuant to sections 510(k), 
     513(f), and 515 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 21 U.S.C. 360(k), 360c(f), or 360e); and
       (3) otherwise meeting the requirements of such Act and such 
     section 351 of the Public Health Service Act.
       (b) Applicability of Certain Categorizations for Premarket 
     Device Review.--In the case of a device receiving an 
     authorization under section 564 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360bbb-3) for which the Secretary 
     has determined, in accordance with subsection (m) of such 
     section, that a laboratory examination or procedure 
     associated with such device is deemed to be in the category 
     of examinations and procedures described in section 353(d)(3) 
     of the Public Health Service Act (42 U.S.C. 262), such 
     determination shall apply with regard to a submission 
     pursuant to section 510(k), 513(f), or 515 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 21 U.S.C. 360(k), 
     360c(f), or 360e) for such device, unless the Secretary 
     (taking into account any applicable conditions specified 
     pursuant to subsection (m)(2) of section 564 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3)) identifies 
     new information not included in the request for authorization 
     that indicates that the criteria under section 353(d)(3) of 
     the Public Health Service Act (42 U.S.C. 262) are not met.
       (c) Rule of Construction.--Nothing in this section shall be 
     construed as altering the review standards or otherwise 
     affecting the requirements under section 505, 510(k), 513(f), 
     or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     21 U.S.C. 355, 360(k), 360c(f), or 360e) or under section 351 
     of the Public Health Service Act (42 U.S.C. 262) for the 
     clearance or approval of a device, approval of a drug, or 
     licensure of a biological product.
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