US SB3512 | 2019-2020 | 116th Congress
Status
Spectrum: Partisan Bill (Republican 2-0)
Status: Introduced on March 17 2020 - 25% progression, died in committee
Action: 2020-03-17 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on March 17 2020 - 25% progression, died in committee
Action: 2020-03-17 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Summary
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.
Title
VITAL Act of 2020 Verified Innovative Testing in American Laboratories Act of 2020
Sponsors
Sen. Rand Paul [R-KY] | Sen. Ted Cruz [R-TX] |
History
Date | Chamber | Action |
---|---|---|
2020-03-17 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Subjects
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
Health facilities and institutions
Infectious and parasitic diseases
Licensing and registrations
Medical tests and diagnostic methods
Nuclear weapons
Public participation and lobbying
Terrorism
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
Health facilities and institutions
Infectious and parasitic diseases
Licensing and registrations
Medical tests and diagnostic methods
Nuclear weapons
Public participation and lobbying
Terrorism
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/116th-congress/senate-bill/3512/all-info |
Text | https://www.congress.gov/116/bills/s3512/BILLS-116s3512is.pdf |