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H.R. 6839House116th Congress (2019-2021)In Committee

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.

Sponsored by Abigail Davis SpanbergerRep. Abigail Davis Spanberger (D-VA)
Introduced May 12, 2020

AI-Generated Summary

Updated April 14, 2026 at 12:18 PM UTC

The bill requires the Government Accountability Office (GAO) to prepare a report, due within 18 months of enactment, on how various entities responded to the COVID‑19 pandemic in developing, evaluating, and deploying diagnostic tests. It covers laboratories, test manufacturers, state and local governments, and key federal agencies such as the FDA and CDC, aiming to assess coordination, standards, and the accuracy of the tests used.

Key Provisions

  • The Comptroller General must submit the GAO report to the House Energy and Commerce Committee and the Senate HELP Committee within 18 months of the bill becoming law.
  • The report must examine actions taken by laboratories, manufacturers, state/tribal/territorial governments, and federal agencies (FDA, CDC, CMS, NIH, etc.) regarding COVID‑19 diagnostic test development and deployment.
  • It must assess how well federal agencies coordinated, the standards the FDA used to evaluate tests, and how clear agency guidance was for the public.
  • The report should detail state and territorial actions that allowed labs to use tests not authorized by the FDA, including how those states evaluated test accuracy and the standards they applied.
  • It must evaluate the validation processes used by labs and manufacturers and provide an assessment of the accuracy and sensitivity of a representative sample of available diagnostic tests.

Legislative Activity

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HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 12, 2020

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HouseIntro Referral

Introduced in House

May 12, 2020

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 12, 2020

Bill Text

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Introduced in HouseIssued May 12, 2020

I

116th CONGRESS

2d Session

H. R. 6839

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 entities to the COVID–19 pandemic with respect to the development, regulatory evaluation, and deployment of diagnostic tests.

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 and the Committee on Health, Education, Labor and Pensions of the Senate a report describing the response of entities described in subsection (b) to the COVID–19 pandemic with respect to the development, regulatory evaluation, and deployment of diagnostic tests.

(b)

Entities described

Entities described in this subsection include—

(1)

laboratories, including public health, academic, clinical, and commercial laboratories;

(2)

diagnostic test manufacturers;

(3)

State, local, Tribal, and territorial governments; and

(4)

the Food and Drug Administration, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and other relevant Federal agencies, as appropriate.

(c)

Contents

The report under subsection (a) shall include—

(1)

a description of actions taken by entities described in subsection (b) to develop, evaluate, and deploy diagnostic tests;

(2)

an assessment of the coordination of Federal agencies in the development, regulatory evaluation, and deployment of diagnostic tests;

(3)

an assessment of the standards used by the Food and Drug Administration to evaluate diagnostic 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 evaluated 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 territories when deciding when to authorize laboratories to develop or perform diagnostic tests;

(6)

an assessment of the steps taken by laboratories and diagnostic test manufacturers to validate diagnostic tests, as well as the evidence collected by such entities to support validation; and

(7)

based on available reports, an assessment of the accuracy and sensitivity of a representative sample of available diagnostic tests.

(d)

Definition

In this section, the term diagnostic test means an in vitro diagnostic product (as defined in section 809.3(a) of title 21, Code of Federal Regulations) 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.