The US Food and Drug Administration (FDA) is launching a program to transform and strengthen the way it currently monitors the safety of medical devices after they reach the market. The FDA Center for Devices and Radiological Health (CDRH) Postmarket Transformation Initiative will protect the public’s health by allowing the FDA to identify, analyze, and act on problems more quickly, including alerting the public sooner of potential medical-device issues.
"Over the next decade, medical-technology innovations will fundamentally transform the health care and delivery system, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered," says Scott Gottlieb, MD, the FDA’s deputy commissioner for medical and scientific affairs. "Under the leadership of our device center’s expert staff, we are working to develop even better ways to evaluate new technologies to maximize benefits and minimize risk, including more efficient ways to develop more effective postmarket systems that can support safer medical practices as well as continued innovation."
To guide this process, the CDRH established the Postmarket Transformation Leadership Team, which consists of senior- level FDA managers and consultants who are experienced in device safety and product regulation. As its first step, the team will review CDRH’s Medical Device Postmarket Safety Program report and accompanying recommendations for possible ways to address areas that need improvement.
Areas on which the initiative will focus include: working toward an electronic reporting system for adverse-medical-device events; ways to identify medical devices, including standardized and globally accepted names; ways to improve device information in patient records; improved internal collaboration on postmarket safety issues; and identifying opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical-device industry.
The Postmarket Transformation Leadership Team is expected to provide recommendations to CDRH within 4 months.