FDA, CMS Form Interagency Task Force On LDT Oversight

FDA and CMS are forming an interagency task force to increase their collaboration on oversight of laboratory developed tests (LDTs), with plans to address a range of issues, such as quality requirements for LDTs, and to clarify the agencies' respective responsibilities. The plan was announced in an FDA Voice Blog Thursday (April 16) in which FDA medical device chief Jeff Shuren and CMS Chief Medical Officer Patrick Conway note stakeholder confusion about the agencies' roles. FDA last year released a...