S. 3516Senate117th Congress (2021-2023)In Committee

Increase Access to COVID Testing Act

AI-Generated Summary

Updated February 8, 2026 at 8:54 AM UTC

The bill directs the Secretary of Health and Human Services to grant emergency use authorizations for COVID‑19 antigen diagnostic tests that are approved for use in the European Union. It applies while the COVID‑19 public health emergency is in effect and covers tests intended for at‑home or other non‑laboratory use without a prescription, affecting manufacturers and U.S. consumers.

Key Provisions

HHS must authorize the interstate sale of EU‑listed antigen COVID‑19 tests upon a manufacturer’s request, without needing to meet the usual specific criteria for emergency use authorization.
The tests eligible for authorization must appear on the European Commission’s common list of rapid antigen tests and be intended for at‑home or other non‑lab use without a prescription.
Authorized tests are subject to the same terms and requirements as other products authorized under the FDA’s emergency use provisions.
If a test is removed from the EU common list, HHS must review within 30 days whether to continue its emergency use authorization.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 18, 2022

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SenateIntro Referral

Introduced in Senate

January 18, 2022

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

January 18, 2022

Bill Text

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Introduced in SenateIssued January 18, 2022

117th CONGRESS

2d Session

S. 3516

IN THE SENATE OF THE UNITED STATES

January 18, 2022

Mr. Sasse introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To require the Secretary of Health and Human Services to provide emergency use authorization with respect to certain COVID–19 diagnostic tests approved for use in the European Union.

Short title

This Act may be cited as the Increase Access to COVID Testing Act.

Emergency use approval of certain COVID–19 tests

(a)

In general

For the duration of the public health emergency declared under section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, the Secretary of Health and Human Services shall authorize the introduction into interstate commerce, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3), without regard for any specific criteria under subsection (c)(2) of such section, of any antigen diagnostic test to detect SARS–CoV–2 that is described in subsection (b), upon request by the manufacturer under such section 564.

(b)

Tests described

An antigen diagnostic test to detect SARS–CoV–2 described in this subsection is such a test—

(1)

that is included on the common list of COVID–19 rapid antigen tests of the European Commission Directorate-General for Health and Food Safety; and

(2)

for which the emergency use authorization request is for an at-home, or other non-laboratory site, use, without a prescription.

(c)

Terms of authorization

(1)

In general

A diagnostic test authorized as described in subsection (a) shall be subject to the same terms and requirements as other products authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3).

(2)

Change in status in the EU

In the case of an antigen diagnostic test authorized as described in subsection (a), if the European Commission Directorate-General for Health and Food Safety removes such test from the common list described in subsection (b)(1), the Secretary of Health and Human Services, not later than 30 days after such removal from the common list, shall conduct a review of the test to determine whether the emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) should continue.