Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed Tests (“Discussion Paper”) on January 13, 2017, detailing the agency’s views on a future approach to LDT regulation. The Discussion Paper synthesizes stakeholder feedback on the 2014 draft guidance, issued in order to “advance public discussion on future LDT oversight.” Though not a binding document and not representative of final agency guidance, the Discussion Paper nevertheless offers insight into potential aspects of a future oversight program and serves as a prompt for legislative action.

The Discussion Paper appears to be FDA’s attempt to signal the agency’s willingness to step away from the contentious regulatory approach set forth in the 2014 draft guidance. Instead, the Discussion Paper proposes a path forward that adopts elements of stakeholder proposals and suggests a more collaborative approach to oversight by spelling out potential roles for each stakeholder. Citing to several oversight proposals prepared by industry organizations, the Discussion Paper points to a growing consensus that more active oversight over LDTs is necessary and highlights common features of each proposal. In addition, the Discussion Paper displays a willingness by FDA to share oversight with the Clinical Laboratory Improvement Amendments (“CLIA”) program, which is overseen by the Centers for Medicare and Medicaid Services (“CMS”).