- FDA commissioner Robert Califf and Jeffrey Shuren, Director of the FDA's for Devices and Radiological Health wrote in a JAMA viewpoint released Monday that medical devices need to be more effectively tracked from clinical trials through to the marketplace.
- The report and call for an updated National Evaluation System for Health Technology (NEST) comes after the FDA had been criticized for allegedly not properly vetting medical devices that would prove to be problematic or even deadly, reports Modern Healthcare.
- Both Shuren and Califf call for strategies that incorporate clincal based data sources and EHRs in monitoring of health devices to help eliminate potential harms, reports the Regulatory Assistance Project.
In 2012, the FDA first took steps to develop a NEST, in an effort to quickly and effectively identify devices with potential harm. The viewpoint follows a report from the Government Accountability Office last year that nearly 90% of the FDA's postmarket surveillance studies over the past seven years were inactive, reports the Regulatory Assistance Project.
In the viewpoint, both Shuren and Califf suggest balancing rigorous premarket trials and postmarket evaluation, in order to encourage device development without sacrificing effective risk assessment. They propose that developing a federated virtual system for evidence, which incorporates data registries and EHRs, will enhance NEST's current structure. They also recommend that NEST be operated by independent coordinating center.
"Essentially, NEST should be of, by, and for the medical device ecosystem and configured to provide maximal value to stakeholders, including the critical data needed by the FDA to make decisions that currently must be made with less comprehensive information," says the report.
The two authors hope that a more effective evaluation system will allow the FDA to better focus its efforts development and to quickly detect issues with medical technologies when they arise. The authors state that a reformed infrastructure for data collection is necessary.
"Ultimately, these changes could contribute to a much more efficient system that rewards innovation that leads to better health outcomes, creating powerful incentives for continuous improvement and accelerating access to technologies that patients and physicians can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk,” they concluded.