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.