ARTICLE | Politics & Policy

FDA, CMS advocate new LDT oversight roles

November 18, 2015 2:02 AM UTC

In testimony before the House Energy and Commerce Subcommittee on Health, FDA's Jeffrey Shuren and CMS's Patrick Conway made the case for FDA to play a larger role in oversight of laboratory-developed tests (LDTs), citing the increased complexity and availability of the tests and their growing role in making diagnostic and treatment decisions.

Conway, CMS's CMO and deputy administrator for innovation & quality, said FDA "can play a critical role in premarket review" of LDTs, while CMS's staff does not have the scientific expertise to conduct premarket review. ...