FDA Plans New Medical-Device Approval Processes

Thomas M. Burton
WASHINGTON—The Food and Drug Administration plans new medical-device approval processes to speed products’ entry to the U.S. market, mirroring the desires of industry and President Donald Trump to clear barriers to new business. FDA commissioner Scott Gottlieb, who has long espoused speedier steps to promote innovation, in an interview called for “progressive,” or stepped, approvals of certain devices that would allow them to go to market with initial approvals, with further evidence to assess performance coming later. That would entail more risk to patients initially than current procedures where clinical trials or other evidence come before market launch. (more…)