Amid Competing LDT Regulatory Proposals, Common Ground but Key Disagreements for Congress to Consider

Overview


Paul Radensky, who represents the Coalition for 21st Century Medicine, said the group “does not support risk-based classifications that identify algorithms or technological features as the basis for assigning risk” in regulating laboratory developed tests (LDTs). The coalition supports a risk-based regulatory framework under FDA that recognizes the differences between clinical diagnostics and medical devices, Mr. Radensky added, noting that current proposals to the contrary still need “substantial work.”