Skip to main content
S 1666 117th Congress Senate Health Administrative law and regulatory procedures Cardiovascular and respiratory health Chemical and biological weapons Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Health facilities and institutions Infectious and parasitic diseases Licensing and registrations Medical tests and diagnostic methods Nuclear weapons Public participation and lobbying Terrorism

VITAL Act of 2021

Introduced: May 18, 2021 Introduced by: Paul, Rand Republican · Kentucky See on congress.gov
Sign in to write a letter Sign in to watch
This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1666: VITAL Act of 2021. 117th Congress. Open America. https://openamerica.io/bill/117-S-1666/
MLA
"S. 1666: VITAL Act of 2021." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-1666/.
Bluebook (legal)
S. 1666, 117th Cong. (2026), https://openamerica.io/bill/117-S-1666/.
Markdown link
[S. 1666: VITAL Act of 2021](https://openamerica.io/bill/117-S-1666/)
Report a problem