I 
116TH CONGRESS 
2D SESSION 
H. R. 6839 
To direct the Comptroller General of the United States to submit a report 
describing the response of certain entities to the COVID–19 pandemic 
with respect to the development, regulatory evaluation, and deployment 
of diagnostic tests. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 12, 2020 
Ms. SPANBERGER (for herself and Mr. GONZALEZ of Ohio) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To direct the Comptroller General of the United States to 
submit a report describing the response of certain enti-
ties to the COVID–19 pandemic with respect to the 
development, regulatory evaluation, and deployment of 
diagnostic tests. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. GAO REPORT ON DIAGNOSTIC TESTS. 
(a) GAO STUDY.—Not later than 18 months after 
the date of enactment of this Act, the Comptroller General 
of the United States shall submit to the Committee on 
Energy and Commerce of the House of Representatives 
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and the Committee on Health, Education, Labor and Pen-
sions of the Senate a report describing the response of 
entities described in subsection (b) to the COVID–19 pan-
demic with respect to the development, regulatory evalua-
tion, and deployment of diagnostic tests. 
(b) ENTITIES DESCRIBED.—Entities described in 
this subsection include— 
(1) laboratories, including public health, aca-
demic, clinical, and commercial laboratories; 
(2) diagnostic test manufacturers; 
(3) State, local, Tribal, and territorial govern-
ments; and 
(4) the Food and Drug Administration, the 
Centers for Disease Control and Prevention, the 
Centers for Medicare & Medicaid Services, the Na-
tional Institutes of Health, and other relevant Fed-
eral agencies, as appropriate. 
(c) CONTENTS.—The report under subsection (a) 
shall include— 
(1) a description of actions taken by entities de-
scribed in subsection (b) to develop, evaluate, and 
deploy diagnostic tests; 
(2) an assessment of the coordination of Fed-
eral agencies in the development, regulatory evalua-
tion, and deployment of diagnostic tests; 
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(3) an assessment of the standards used by the 
Food and Drug Administration to evaluate diag-
nostic tests; 
(4) an assessment of the clarity of Federal 
agency guidance related to testing, including the 
ability for individuals without medical training to 
understand which diagnostic tests had been evalu-
ated by the Food and Drug Administration; 
(5) a description of— 
(A) actions taken and clinical processes 
employed by States and territories that have 
authorized laboratories to develop and perform 
diagnostic tests not authorized, approved, or 
cleared by the Food and Drug Administration, 
including actions of such States and territories 
to evaluate the accuracy and sensitivity of such 
tests; and 
(B) the standards used by States and ter-
ritories when deciding when to authorize labora-
tories to develop or perform diagnostic tests; 
(6) an assessment of the steps taken by labora-
tories and diagnostic test manufacturers to validate 
diagnostic tests, as well as the evidence collected by 
such entities to support validation; and 
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(7) based on available reports, an assessment of 
the accuracy and sensitivity of a representative sam-
ple of available diagnostic tests. 
(d) DEFINITION.—In this section, the term ‘‘diag-
nostic test’’ means an in vitro diagnostic product (as de-
fined in section 809.3(a) of title 21, Code of Federal Regu-
lations) for— 
(1) the detection of SARS–CoV–2; 
(2) the diagnosis of the virus that causes 
COVID–19; or 
(3) the detection of antibodies specific to 
SARS–CoV–2, such as a serological test. 
Æ 
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