Ensuring Patient Safety and Benefit in Use of Medical Devices Granted Expedited Approval

This book chapter examines how legislative and regulatory efforts to streamline medical device approval in the United States — including the Breakthrough Devices Program and 510(k) pathway — have increased uncertainty about device safety and effectiveness. The authors recommend that expedited device approvals be made contingent on timely completion of mandatory postmarket studies demonstrating safety and effectiveness, with automatic lapse of approval if milestones are not met, alongside improved patient disclosure to support informed consent.