Increase Access to COVID Testing Act

Senate Bill 3516 - Increase Access to COVID Testing Act: Overview, Status, and Impact

Hozzl · 2024-03-13T02:38:59Z

Explore the details of Senate Bill 3516 Increase Access to COVID Testing Act currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

3/13/2024, 2:38 AM

Congressional Summary of S 3516

Increase Access to COVID Testing Act

This bill directs the Food and Drug Administration (FDA) to provide upon request emergency use authorization for COVID-19 rapid antigen tests approved for use in the European Union.

During the declared COVID-19 public health emergency, the FDA shall grant emergency use authorization to a COVID-19 rapid antigen test upon a proper request by the test's manufacturer if (1) the test is on the European Commission Directorate-General for Health and Food Safety's common list for approved COVID-19 tests, and (2) the request is for the non-laboratory use of the test without a prescription.

The bill waives certain requirements for a request for emergency use authorization under this bill, such as a finding from the FDA that the test may be effective in diagnosing COVID-19.

If a test authorized under this bill is removed from the EU common list, the FDA must determine within 30 days of such removal whether the emergency use authorization for the test should continue.

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Current Status of Bill S 3516

Bill S 3516 is currently in the status of Bill Introduced since January 18, 2022. Bill S 3516 was introduced during Congress 117 and was introduced to the Senate on January 18, 2022. Bill S 3516's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of January 18, 2022

Bipartisan Support of Bill S 3516

Total Number of Sponsors

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill S 3516

Primary Policy Focus

Health

Potential Impact Areas

- Cardiovascular and respiratory health

- Drug safety, medical device, and laboratory regulation

- Emergency medical services and trauma care

- Europe

- European Union

- Infectious and parasitic diseases

- Medical tests and diagnostic methods

Alternate Title(s) of Bill S 3516

Increase Access to COVID Testing Act

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.