CDRH’s vision is that patients in the US have access to high quality, safe and effective medical devices of public health importance first in the world. Ten years ago, the medical device regulatory landscape was perceived to have limited options for bringing new therapies and devices to patients in a timely manner. Today, however, that outlook has changed due in part to the significant efforts that FDA has taken to advance medical device innovation and safety by focusing on our vision. This presentation will provide an overview of multiple CDRH initiatives across the total product lifecycle ranging from streamlined regulatory approaches for clinical studies to new programs for expediting review of devices which address unmet medical needs, and increased opportunity for using real world evidence to support regulatory submissions.
Maureen Dreher, PhD, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health (CDRH)