S 3512 · 116th Congress 2019–2021, ended

VITAL Act of 2020

Fact sheet

Latest action · Mar 17, 2020 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedMar 17, 2020
  2. Passed SenateNot reached
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Verified Innovative Testing in American Laboratories Act of 2020 or the VITAL Act of 2020

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.

Cosponsors 1

Members who signed on, in the order they did. All signed on Mar 19, 2020.

SeatCosponsorSigned on
R-TXTed CruzMar 19, 2020

Actions 2

Everything that happened, newest first.

  1. Mar 17, 2020Introduced in Senate
  2. Mar 17, 2020Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Mar 17, 2020Introduced in Senate

Support LegiList

This page is free, carries no paywall, and is built and maintained by one person. If the record here is useful to you, a few dollars keeps it going.

Processed by Stripe in a separate window. LegiList never sees card details.

Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.