Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness

HARNESSING THE DIGITAL REVOLUTION FOR MEDICAL
DEVICE EVALUATION

Medical Device Evaluation

Mark your calendars for Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness, a symposium jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation and the Food and Drug Administration.

Date Thursday, March 24, 2016
Time 8:30 a.m. to 4:30 p.m.
Location University of Maryland School of Pharmacy
20 N. Pine Street, Room N103
Baltimore, MD 21201

About the Event:

To successfully harness relevant information from diverse sources of real-world evidence, the United States must develop the necessary infrastructure, which is not yet in place today. The high costs and inefficiencies of data generation in traditional clinical trials have created disincentives for innovators to study new technologies in the U.S., and ultimately bring their products to patients in the U.S. first. Limitations of current post-market surveillance tools, such as passive reporting, also constrain our ability to rapidly address safety concerns. A national evaluation system for medical devices that leverages real-world evidence can help the Food and Drug Administration (FDA) strike a balance between pre-market and post-market data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the post-market period.

However, the promise of using real-world evidence to promote the safety and effectiveness of medical devices can only be achieved through robust public-private partnerships and new approaches to informatics, epidemiology, biostatistics, and health care data systems integration. The foundation (strategy and steps) for the development of a national evaluation system for medical devices has been developed by the FDA's Center for Devices and Radiological Health, and in 2015, two multi-stakeholder groups issued reports that develop the science and provide recommendations that further the establishment of this system.

Scheduled for Thursday, March 24, 2016, Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness will provide clinicians, researchers and others from the medical device industry, professional societies, health care delivery systems, patient advocacy groups, and the FDA the opportunity to discuss this important topic. Presenters will discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. The role that Unique Device Identification (UDI) plays in improving device evaluation to support more informed clinical and patient decision-making and device innovation will also be discussed.

References:

The FDA’s Center for Devices and Radiological Health (CDRH) has described the foundation (strategy and steps) for the development of the National Evaluation System for Medical Devices in the following documents:

  1. Strengthening Our National System for Medical Device Postmarket Surveillance, September 2012.
  2. Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps, April 2013.

In addition, two multi-stakeholder groups have issued reports that develop the science and provide recommendations for further establishment of the National Evaluation System for Medical Devices:

  1. Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, The Engelberg Center for Health Care Reform at the Brookings Institution, February 2015.
  2. Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge Clinical Care and Research, Medical Device Registry Task Force and the Medical Devices Epidemiology Network, August 2015.

About the Organizers:

 Center of Excellence in Regulatory Science and Innovation (CERSI) A collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore, with support from the Food and Drug Administration (FDA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.


Food and Drug Administration
The Food and Drug Administration (FDA) works to protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. The organization also strives to advance public health by helping to speed innovations that make medicines more effective, safer, and more affordable.

For More Information:

More information about this conference, including registration, an agenda, and parking and accommodations, is available on this website.