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# Covid Test EUAs ‘Deadliest Regulatory Overreach’: Article
- URL: https://www.fdaweb.com/covid-test-euas-deadliest-regulatory-overreach-article/
- Published: 2020-07-29T12:00:00.000Z
- Updated: 2026-09-14T16:22:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147311

Two law professors say that FDA guidances on seeking emergency use authorizations for new Covid-19 tests contributed to the delay in rolling out tests and, because some agency actions were not supported by law, “FDA’s interference in areas Congress had not authorized the agency to regulate was an overreach, possibly the deadliest regulatory overreach in U.S. history.” Writing in the *Yale Law Journal*, the professors [say](https://www.yalelawjournal.org/forum/deadly-delay-the-fdas-role-in-americas-covid-testing-debacle?ref=fdaweb.com) the guidances had a practical binding effect that subjected laboratory services to FDA oversight that may have cost time in a context where lost time meant lost lives.

“It will be critical to understand whether FDA’s review, which essentially duplicated the internal validation procedures laboratories already must perform under the Clinical Laboratories Improvement Act (CLIA), added sufficient value to make the cost of delay and burdens on smaller labs worthwhile,” the article says. “It also is crucial to ask whether one-size-fits-all FDA jurisdiction to regulate all laboratory-developed tests (LDTs), as proposed in the VALID Act, is good policy. Genetic, genomic, and other advanced molecular diagnostic tests may raise special concerns that require tailored policy solutions.”

The authors say that the 3/5 introduction of the Verifying Accurate Leading-edge IVCT (in vitro clinical test) Development Act of 2020 (VALID Act) would empower FDA to regulate LDTs, which traditionally have been treated as part of CLIA-regulated laboratory services rather than as FDA-regulated medical devices.

They say it is good that Congress has not yet approved the VALID Act because “the Covid-19 testing debacle displays weaknesses in the VALID Act’s approach.” They say that approach caused “deadly delays” when applied to LDTs for SARS-CoV-2 testing and the bill needs “careful tailoring before being applied to all LDTs…. Before Congress acts on specific legislative proposals, there needs to be a much broader, more inclusive, nuanced, and evidence-informed dialog about diagnostic-testing policy.”