Megan’s point of view: The federal court's decision to vacate the FDA's LDT Final Rule, influenced by the Supreme Court's Loper decision, highlights a significant shift in limiting agency authority. This is a potential win for industries challenging regulatory overreach, while also emphasizing the need for alternative legislative or state-level solutions to address the regulatory grey areas surrounding laboratory-developed tests.
Following is an excerpt from BioSpace, “Opinion: Fate of FDA’s Laboratory-Developed Test Final Rule Hints at Chevron Overturn’s Ramifications,” by Megan Robertson:
In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency authority, a judge ruled that the FDA does not have authority to regulate tests developed by clinical laboratories.
On March 31 of this year, a federal district court judge blocked the FDA’s most recent effort to regulate laboratory developed tests as in vitro diagnostic medical devices. With explicit reference to the Supreme Court’s 2024 Loper decision overturning the longstanding Chevron deference doctrine, this ruling serves as an early look at how the Loper decision may impact agency regulatory authority going forward.
Laboratory-developed tests (LDTs) are generally understood as tests or test systems that are designed, developed and used by a CLIA-certified high complexity clinical laboratory. This is in contrast to tests or test systems that are centrally manufactured by non-laboratories and sent to labs or providers ready for use, which have long been regulated as medical devices. The FDA has always maintained that it has the authority to regulate LDTs as in vitro diagnostic medical devices. However, for many years it permitted labs an exemption from premarket approval requirements through enforcement discretion so long as they maintained their CLIA certificate through the Centers for Medicare & Medicaid Services (CMS), and the test itself did not raise significant safety concerns. As technology and industry advanced, however, those agency safety concerns started to become more frequent due to the expansion and increasing complexity of LDTs.
As an attorney representing stakeholders in the clinical laboratory, med tech and biopharma industries, LDTs are, in my experience, one of the most notorious examples of a regulatory grey area in the life sciences universe. Are they medical devices, professional services or some blend of both?
