Medical and Regulatory Affairs

Stronger Post-Market Studies Needed if FDA Speeds New Medical Device Approval

Big changes are planned in 2018 and beyond for how new medical devices are reviewed and approved by the U.S. Food and Drug Administration (FDA) if a proposal put forth moves forward. In a blogpost this week, FDA Commissioner Scott Gottlieb, M.D. announced the FDA’s Center for Devices and Radiological Health (CDRH) will publish a series...