The US Food and Drug Administration (FDA) has published a much-anticipated proposed rule that aims to end its enforcement discretion of laboratory-developed tests (LDT) and make it explicitly clear that the products will be regulated by the agency as medical devices. FDA argues that the rule will encourage innovation while saving patient lives and billions in healthcare costs.
Almost a year ago, FDA Commissioner Robert Califf expressed his frustration with the fact that despite years of trying, Congress had not passed the Verifying Accurate, Leading-edge IVCT Development (VALID) Act to create a regulatory framework for in-vitro diagnostics (IVD) and institute a new pathway for LDT oversight (Related: Califf: FDA may use rulemaking for diagnostics reform if VALID isn’t passed, Regulatory Focus 25 October 2022)…
