Title: A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.
Policy area: Health

Summary:
This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product.
Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval.
Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1508 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 1508

  To provide for the use of emergency use authorization data and real 
   world evidence gathered during an emergency to support premarket 
applications for drugs, biological products, and devices, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 29, 2021

 Mr. Marshall (for himself, Ms. Smith, and Mr. Cassidy) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To provide for the use of emergency use authorization data and real 
   world evidence gathered during an emergency to support premarket 
applications for drugs, biological products, and devices, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. USING EMERGENCY USE AUTHORIZATION DATA AND REAL WORLD 
              EVIDENCE GATHERED DURING AN EMERGENCY TO SUPPORT 
              PREMARKET APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, 
              AND DEVICES.

    (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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