One of the unforeseen results of the coronavirus public health emergency has been to bring the perennial controversy over U.S. Food and Drug Administration (FDA) premarket regulation of laboratory developed tests (LDTs) to a head. As the crisis has deepened, the agency has found itself in the position of backing away from its hands-on approach and has allowed laboratories and test makers greater discretion in launching LDTs detecting the SARS-CoV-2 virus. And now a new Administration pronouncement carries that policy to a new and significant level. The Controversy Over FDA LDTs Regulation Laboratory tests were not included in the original legislation that created the FDA and current regulatory system of medical drug and device regulation. So, the agency has relied on its powers to regulate devices. Accordingly, 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.  The HHS Decision And now the U.S. Department of Health and Human Services (HHS) has taken the same position. On August 19, HHS […]