SOP/FDA Talk Post-Market Device Regulation

March 22, 2016    |  

Collecting and analyzing real-world evidence could help ensure the safety and efficacy of implantable medical devices once they have hit the market. However, the infrastructure necessary to gather and process this post-market data collection does not currently exist. The University of Maryland School of Pharmacy and the U.S. Food & Drug Administration (FDA) have partnered to examine this issue in-depth. A daylong conference at the School of Pharmacy on Thursday, March 24 will gather experts to consider the problem and potential solutions. The conference and the partnership are part of the Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), an FDA-funded collaboration between the University of Maryland, Baltimore and the University of Maryland, College Park (UMCP).

“More and more people are living with implantable devices, and at increasingly younger ages,” says conference organizer Fadia Tohme-Shaya, PhD, MPH, professor and vice chair for academic affairs of the Department of Pharmaceutical Health Services Research at the School of Pharmacy. “We need to work toward a system that informs providers and patients in real time about what is the best device option for them at the time they need it, and provide enough data to weigh risk and benefit. These decisions are often irreversible. Unlike the arguable ease of switching medications, the decision to replace an implantable device is often very difficult if not impossible.”

The issue surrounds the safety of implantable medical devices such as heart stents, pacemakers, hip and other prosthetics. The collection of data after a medical device has met regulatory approval – real-world evidence gathered once the device is in use in the marketplace – could provide valuable information to improve device safety and effectiveness. But to collect and analyze that data, a new system is necessary. This infrastructure would require strong public-private partnering and innovations in informatics, epidemiology, biostatistics, and health care data systems integration. The FDA’s Center for Devices and Radiological Health (CDRH) has laid a foundation for a new national evaluation system for medical devices, and last year two multi-stakeholder groups issued reports providing recommendations on moving the project forward.

The conference, “Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness,” will bring together clinicians, researchers, and representatives from the medical device industry, professional societies, health care delivery systems, patient advocacy groups and the FDA. Presenters include Tohme-Shaya; the director of the FDA’s CDRH Jeff Shuren, MD, JD; Greg Pappas, MD, PhD, associate director for national device evaluation at CDRH; representatives of the MDEpiNet, a public-private partnership devoted to ensuring the safety and efficacy of post-approval medical devices; and many more researchers from the FDA, the National Institutes of Health, PCORnet, the National Library of Medicine, and other schools and universities, including Weill Cornell Medical College, Duke University, the University of Maryland School of Medicine, and UMCP.

Media are welcome to attend. For more information or to speak with the conference organizers, please contact Karen Robinson, 410-706-0023,