The U.S. Food and Drug Administration (FDA) is launching a new program to transform and strengthen the way it currently monitors the safety of medical devices after they reach the market both new technology and existing products.
The FDA Center for Devices and Radiological Health's (CDRH) Postmarket Transformation Initiative will better protect the public 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," said Dr. Scott Gottlieb, 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 post-market systems that can support safer medical practices as well as continued innovation."
Areas in which this initiative will focus include:
-- Working toward an electronic reporting system for adverse medical device events;
-- Unique ways to identify medical devices including standardized and globally accepted names
-- Ways to improve device information in patient records
-- Improved internal collaboration on post market safety issues
-- Identifying opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical device industry
The FDA undertook this initiative after a comprehensive, year-long internal inventory of the tools used to monitor the safety of medical devices after they are approved. This inventory identified many areas that are working well; however, it also identified challenges associated with medical devices after they reach the market.
"With this initiative, FDA intends to improve the way it monitors the safety of medical devices and provide a strong safety net to protect public health," said Daniel Schultz, MD, director of the Center for Devices and Radiological Health.
To guide this process, the CDRH Postmarket Transformation Leadership Team has been established consisting of senior level FDA management as well as outside consultants who are experienced in device safety and product regulation. As the 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.
The CDRH Postmarket Transformation Leadership Team is expected to have recommendations back to CDRH within approximately four months.
Source: FDA
The Next Frontier in Infection Control: AI-Driven Operating Rooms
Published: July 15th 2025 | Updated: July 15th 2025Discover how AI-powered sensors, smart surveillance, and advanced analytics are revolutionizing infection prevention in the OR. Herman DeBoard, PhD, discusses how these technologies safeguard sterile fields, reduce SSIs, and help hospitals balance operational efficiency with patient safety.
Targeting Uncertainty: Why Pregnancy May Be the Best Time to Build Vaccine Confidence
July 15th 2025New national survey data reveal high uncertainty among pregnant individuals—especially first-time parents—about vaccinating their future children, underscoring the value of proactive engagement to strengthen infection prevention.
CDC Urges Vigilance: New Recommendations for Monitoring and Testing H5N1 Exposures
July 11th 2025With avian influenza A(H5N1) infections surfacing in both animals and humans, the CDC has issued updated guidance calling for aggressive monitoring and targeted testing to contain the virus and protect public health.
IP LifeLine: Layoffs and the Evolving Job Market Landscape for Infection Preventionists
July 11th 2025Infection preventionists, once hailed as indispensable during the pandemic, now face a sobering reality: budget pressures, hiring freezes, and layoffs are reshaping the field, leaving many IPs worried about their future and questioning their value within health care organizations.