FDA Lacks Authority To Overhaul LDT Regs, Diagnostic Experts Say

Editor's Note: This story has been updated so it no longer describes ACLA as a "vocal supporter of VALID." FDA lacks authority to overhaul its regulation of laboratory-developed tests through rulemaking, without legislative authority from Congress, diagnostic test policy and industry legal experts told Inside Health Policy after FDA chief Robert Califf reportedly threatened to move forward with rulemaking if Congress fails to pass legislation to reform the agency’s LDT regulatory framework. One lawyer believes Califf’s comments...