Senate Bill Establishes Greater Regulatory Oversight Of Lab Developed Tests

Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.

United States Capitol Building at sunset - Washington, DC, USA - Image — • Source: Alamy

As it stands now, laboratory developed tests (LDTs) do not need clearance or approval from the US Food and Drug Administration before hitting the market, so long as the tests were developed in a lab that meets the guidelines as outlined under the Clinical Laboratory Improvement Amendments (CLIA), federal standards regulating testing facilities enacted in 1988.

But that could change if draft legislation out of the Senate Health, Education, Labor and Pensions (HELP) Committee becomes law.