FDA Adds Significant Enforcement Discretion ‘Carve Outs’ In Final LDT Rule

FDA has finalized its controversial rule asserting authority over laboratory-developed tests (LDTs) with some concessions to the barrage of negative feedback it received from industry stakeholders, including adding more categories of tests that will continue to receive enforcement discretion. While FDA says the exemptions are necessary to avoid discouraging companies from producing LDTs and ensure patient access to critical tests, a legal expert says the real reason could be to prevent FDA from running out of resources to enforce its...