The U.S. Food and Drug Administration has proposed a new rule seeking to amend FDA regulations to identify laboratory-developed tests (LDTs), or in vitro diagnostic products (IVDs) produced within a single clinical laboratory, as devices under the Federal Food, Drug, and Cosmetic Act and increase FDA oversight of LDTs, the agency announced Sept. 29.
“Although historically the FDA has generally exercised enforcement discretion over most LDTs, meaning that the agency generally has not enforced applicable requirements with respect to most LDTs, the risks associated with most modern LDTs are much greater than the risks that were associated with LDTs used decades ago,” the FDA writes in a press release. “The agency has become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests and others complying with FDA requirements.”
The FDA intends to phase out its general enforcement discretion approach to LDTs to “better protect public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while avoiding undue disruption to the testing market,” the agency writes. After the phaseout, the FDA would expect IVD makers to meet the same applicable requirements, except when meeting certain requirements under the Clinical Laboratory Improvement Amendments.
The FDA has also proposed alternative enforcement approaches for some IVDs offered as LDTs, including a different approach for academic medical center laboratories, continuation of current general enforcement discretion as pertains to premarket review and quality system requirements for currently marketed LDTs, a phaseout period tailored to small laboratories, and leveraging programs like the New York State Department of Health Clinical Laboratory Evaluation Program or programs within the Veterans Health Administration.