The FDA published its final rule on Laboratory Developed Tests on 6 May 2024, with a 4-stage phase-in concluding 6 May 2028.
Three strategic options: (1) operate within FDA enforcement discretion (narrow), (2) file 510(k)/De Novo/PMA, or (3) restructure your operations to take advantage of preserved enforcement discretion categories (e.g., human leukocyte antigen tests, certain unmet need tests).
Our recommendation for most labs: stand up MDR reporting, complaint files and corrections/removals (Stage 1, due May 2025) regardless of strategy. These are baseline quality activities that cost little and de-risk your future.