House Democrats Urge HHS Secretary to Restore FDA Authority of COVID-19 Lab Developed Tests

May 28, 2021

Last August.under the Trump Administration, HHS announced that FDA would not have premarket review authority and oversight over laboratory developed tests (LDTs), including for COVID-19 tests and EUAs.

Recently, House Energy and Commerce Committee Democrats sent a letter to HHS Secretary Becearra uring that he reverse the decision of the previous administration and reinstate FDA authority and oversight of COVID-19 LDTS.

The trade association for the clinical laboratory industsy, the American Clinical Laboratory Association (ACLA). has also weighed in with a letter to Becerra, urging that any reset of FDA authority ensure that LDTS are not regulated as medical devices, but rather under a separate and distinct framework for diagnostics that shoud be established through legislation.

The issue of LDT regulation brings into play two contrasting pieces of legislation. The VITAL Act, which was reintroduced by Sen. Rand Paul (R-KY) last week, would essentially establish regulatory authority under CMS through enhancements to the Clinical Laboratory Improvement Amendments (CLIA). That approach has long been advocated by the Association of Molecular Pathologists (AMP) and the Association of Pathology Chairs (APC)..

On the flip side, is the VALID Act which would create a new diagnostic regulatory framework under the FDA as opposed to either FDA medical device regulation or CLIA.. ACLA and a number of national laboratories support this approach and want to work with Congress to put in place an appropriate FDA regulatory construct.