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VITAL Act of 2021

Introduced: May 18, 2021 Introduced by: Paul, Rand Republican · Kentucky See on congress.gov
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 18, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 18, 2021
Introduced in Senate
 Plain-English summary Congressional Research Service

Verified Innovative Testing in American Laboratories Act of 2021 or the VITAL Act of 2021

This bill expressly shifts the regulation of laboratory-developed testing procedures from the Food and Drug Administration (FDA) to the Centers for Medicare & Medicaid Services (CMS). Under current law, the FDA regulates the safety and effectiveness, as well as quality of design and manufacture, of laboratory-developed tests, while the CMS regulates clinical laboratories and testing processes. Historically, the FDA has exercised enforcement discretion and not enforced certain statutory and regulatory requirements with respect to these tests.

The CMS must hold a public meeting to solicit recommendations to update existing regulations related to clinical laboratories, and the Department of Health and Human Services must report specified information to Congress, including an assessment of the availability and use of laboratory-developed testing procedures during the COVID-19 (i.e., coronavirus disease 2019) response.

What's happening now May 18, 2021

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

 Committees of jurisdiction 1