National Evaluation System For Medical Devices Under Development By FDA

Federal regulators indicate that they are working on a national evaluation system for medical devices, which is designed to better track performance, helping provide doctors and patients with better information to make informed health care decisions and aid in the regulatory process as well. 

The FDA announced the plan on April 4, as part of an effort to strengthen its post-market surveillance of medical devices. The national evaluation system‘s creation is part of the agency’s 2016-2017 strategic priorities (PDF). The plan’s details were released this month in a report (PDF) by the Duke-Margolis Center for Health Policy.

“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,” the agency’s announcement states. “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.”

The idea was first born from a stakeholder meeting in 2013, which led to a 2015 report on the development of a national post-market surveillance system.

In recent years, the FDA has faced sharp criticism from a number of sources over its post-market surveillance efforts involving both drugs and medical devices, including grassroots organizations, lawmakers, and the Government Accounting Office (GAO). The agency has been criticized over its approval and surveillance of a number of controversial devices, such as the Essure birth control implant and metal-on-metal hip replacement systems.

In addition, the GAO issued a report in January warning that the FDA was approving too many drugs via fast-track approval processes and then failing to monitor those drugs’ effects on patients to ensure they are actually safe.

The FDA hopes that the national evaluation system will help alleviate the post-marketing surveillance problems for its medical devices.

“Real-world evidence in the future will be able to support regulatory decision making across the pre- and postmarket continuum,” the FDA’s strategic priorities plan states. “To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for regulatory decision making, that data flows seamlessly between systems, and that unique device identifiers (UDI) are routinely incorporated into electronic health information.”

The UDIs, which are being implemented through recent FDA regulations, are designed to help track medical devices and identify potential problems with approved products earlier, allowing federal regulators to issue recalls or require safety improvements.