Lexology November 30, 2023
On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Traditionally, the FDA exercised enforcement discretion over LDTs, meaning that the FDA has not enforced applicable requirements regarding most LDTs, recognizing their limited scope in diagnosing rare diseases and their use in controlled clinical settings. However, the evolution of LDTs, including their increased complexity and broader application, has caused the FDA to “become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests or other complying with FDA requirements,” according to...
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