By Kelly A. Briganti, Editorial Director, G2 Intelligence
Asserting that the agencies’ regulatory roles are not duplicative, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (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 the Clinical Laboratory Improvement Amendments (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.
“We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts,” said Jeffrey Shuren, M.D., J.D., the FDA’s Director of the Center for Devices and Radiological Health, and Patrick H. Conway, M.D., MSc, Acting Principal Deputy Administrator CMS Chief Medical Officer, in an FDA Voice April 16, 2015 post announcing the task force. Shuren and Conway further clarify that FDA oversees analytical validity and clinical validity of the tests, making sure they accurately detect analytes and measure or detect the condition for which the test is being used. 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. The task force will be charged with finding ways to improve collaboration between the agencies, identify similar requirements under FDA and CLIA regulations, explain laboratory obligations under each agency’s regulatory requirements, and “maximize efficiency” of the agencies’ efforts. The task force also intends to resolve differences in the terminology each agency uses. The FDA indicated it is still reviewing public comments on the Framework issued last year and continues to welcome feedback which can be submitted to LDTFramework@fda.hhs.gov. Future webinars and other education outreach efforts are promised.