FDA and CMS Announce Joint Task Force Focusing on LDT Regulation

Asserting that the agencies’ regulatory roles are not duplicative, the FDA and CMS announced formation of a joint task force concerning oversight of laboratory developed tests (LDTs). Responding to criticism that FDA regulation of LDTs is unnecessary due to CMS oversight under CLIA, the announcement emphasized that the FDA’s focus is on the quality of the tests while CMS concentrates on the laboratories and their processes—not the individual tests developed by those laboratories. The FDA’s focus will be on the design and manufacture of the test. By contrast, CMS scrutinizes laboratory processes, ensuring quality laboratory operations and qualified staffing. The announcement stressed that CLIA regulations “do not require premarket review of tests or any evidence that a test is clinically valid” and described FDA and CMS oversight as collaborative rather than duplicative. Each agency will contribute members to the task force from their leadership and subject matter experts.