FDA’s proposed rule for the regulation of laboratory-developed tests

Abstract

In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs).The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), including modified FDA-approved/ cleared tests.We outline here concerns from the clinical and public health microbiology laboratory perspective.It is our opinion that LDTs performed by individual Clinical Laboratory Improvement Amendments-certified diagnostic laboratories should not be regulated in the same way as commercial IVDs.This rule, if finalized, will negatively impact the diagnostic services currently offered by clinical and public health laborato ries and, therefore, patients and the providers who care for them.Ending enforcement discretion will likely stifle diagnostic innovation and decrease access to diagnostic testing and health equity.Furthermore, the lack of infrastructure, including personnel and funding, at the FDA and diagnostic laboratories to support the required submissions for review is an obstacle.Like the FDA, diagnostic laboratories prioritize patient safety, accurate clinical diagnostics, and health equity.Since the scope of the LDT landscape is currently unknown, we are supportive of a registration process, along with non-burden some adverse event reporting, to first understand the scope of clinical use of LDTs and any associated safety concerns.Any regulatory rule should be based on data that have been gathered systematically, not anecdotes or case reports.A rule must also balance the potential negative impact to patient care with realistic safety risks for infectious disease diagnostics.KEYWORDS enforcement discretion, in vitro diagnostics, CLIA L aboratory developed tests (LDTs) are regulated through two separate frameworks; the Medical Device Amendments, which granted the Food and Drug Administration (FDA) broad authority over diagnostic tests more than 45 years ago, and the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which provides for the oversight of laboratory practices.These two laws are carried out by the FDA and the Centers for Medicare & Medicaid Services (CMS), respectively, and until the proposed rule was published on October 3, 2023, the FDA considered enforcement discretion sufficient for LDTs (1).However, the agency focused its attention on oversight of commercial test kits, which were manufactured, broadly marketed, and sold for use in many facilities.Meanwhile, under CLIA, laboratory standards are set and enforced for any facilities that test human specimens for health assessment or to diagnose, prevent, or treat disease.CLIA, which is enforced by CMS (in partnership with the Centers for Disease Control and Prevention [CDC]), establishes performance characteristics relating to analytical validity for the use of that test system in the laboratory's environment.CLIA regulations establish quality standards for laboratory testing performed on human specimens for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health.While CLIA

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