On Oct. 9, the U.S. Food and Drug Administration (FDA) dropped a bombshell by announcing that it would no longer review applications for Emergency Use Authorization (EUA) submitted by test makers for laboratory developed tests (LDTs) to diagnose COVID-19. The announcement, which caught the laboratory industry by surprise, came weeks after the Department of Health and Human Services (HHS) announced that the FDA would no longer be able to regulate LDTs by informal decrees but would instead have to go through the customary notice and comment rulemaking process required for new regulations. The Context: FDA Regulation of LDTs The original legislation that created the FDA and current regulatory system of medical drug and device regulation did not specifically provide for oversight of diagnostic laboratory tests. So, the agency has relied on its powers to regulate devices to regulate laboratory tests. That is the reason why LDTs must obtain premarket approval through the 510(k) pathway for medical devices. In addition to challenging the FDA’s authority over LDTs, the laboratory industry has long objected to the agency’s practice of skirting the regulatory process and relying on guidance, website statements and other informal issuances to make regulatory policy. Without clear and codified regulation, […]