E&C Proceeds With Contentious Priority Review For Breakthrough Devices

The latest version of the House 21st Century Cures draft pushes through a proposal to allow breakthrough medical devices -- including 510(k)s -- to receive priority FDA review, even though the measure received pushback from consumer and research advocates, as well as complaints from state Medicaid directors that expediting approval of devices through “breakthrough” designations could pose safety risks for Medicaid patients. The proposal from the Energy and Commerce Committee goes a step further than a recent FDA plan to...