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Will the National Medical Device Evaluation System make medical devices safer?


Edwards & Ragatz is your Jacksonville injury lawyer company.The FDA will have a national “coordinating center” that will review medical devices.  This voluntary system was proposed by the National Medical Device Evaluation System Planning Board, created by the FDA, the Brookings Center for Health Policy, and the Duke-Margolis Center for Health Policy. According to the report, it would create a hub for different areas of the field to share information, with the intention to improve health care and lower costs.

The board said, “We are entering a world with previously unimaginable amounts of medical device data and the potential for much more sophisticated understanding of health and medical issues. To reach the goal of providing better information and care for patients, a coordinated effort to establish broadly supported processes and policies for medical device data sharing, protection and evaluation is needed. Major efforts to enact institutional and cultural change across the medical device community will require multi-stakeholder collaboration and cannot be sustained by federal or private action alone.”

The coordinating center would likely approve manufacturers’ devices faster as the FDA and other agencies will have access to information more quickly and easily. Collection of data would then be more accessible once devices are released to market, which according to the report, would make physicians more knowledgeable about the devices they are using. Edwards & Ragatz is your Jacksonville injury lawyer. More knowledge means more known risks to inform you of.

In addition, the collaborative national evaluation system will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims. A national evaluation system will help improve the quality of real-world evidence that health care providers and patients can use to make better informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access.

Members of the board include members from the Office of the National Coordinator for Health Information Technology, the American Medical Association, Mercy Health System, the Center for Biotechnology and Law at the University of Houston Law Center, Kaiser Permanente, Yale-New Haven Hospital, the National Institutes of Health, Aetna Inc., Anthem Inc., Medtronic Inc., the Centers for Medicare & Medicaid Services, The Parkinson Alliance and others.

The report says the center would serve as a “clearinghouse of expertise and advanced methods, tools, standards and best practices.”

The National Medical Device Evaluation System was recommended by the board to organize as a non-profit and run as a public-private partnership, with members on the board from both sides.

Will it improve the quality and efficiency of medical devices?  We will see.

If you or a loved one suffered from any form of medical malpractice, allow a Jacksonville injury lawyer to provide a free consultation. Contact an esteemed personal Jacksonville medical malpractice attorney at Edwards & Ragatz for a free consultation: (904) 295-1050 or through our website

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