ABSTRACT. In response to the COVID-19 pandemic, the U.S. Food and Drug Administration
(FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations
(EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed
for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity
clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments
of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response
to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as
having a practical binding effect even though the FDA lacked clear statutory authority to require
EUAs for LDTs developed at CLIA-compliant high-complexity laboratories. The FDA’s guidance
documents led to decreased availability of testing, particularly in the early stages of the pandemic,
which contributed to the catastrophic course of the COVID-19 pandemic in the United States.
This Essay concludes that the FDA lacks authority to require EUAs for COVID-related LDTs and
that the FDA’s intervention, in key respects, just replicates protections CLIA already provides. The
Essay then discusses recently proposed legislation, known as the VALID Act of 2020, which would
expand the FDA’s authority to regulate LDTs. While spurred by longstanding concerns about tests
used in genomics and precision medicine, the VALID Act’s reach is much broader and would have
harmful consequences for more traditional tests, including tests for emerging communicable diseases.
Before Congress acts on specific legislative proposals, a much broader, more inclusive, nuanced,
and evidence-informed dialogue about diagnostic-testing policy is needed.