National evaluation system could speed medical device approvals, innovation

Front of office building for FDA

A national evaluation system for health IT could provide essential data to the U.S. Food and Drug Administration to help officials make better decisions about medical devices and further spur innovation, according to a viewpoint published in the Journal of the American Medical Association.

The post's authors, FDA's Jeffrey Shuren and Robert M. Califf, call for a strategic approach linking data sources such as registries, electronic health records and claims data to provide a source of clearer evidence of risks and benefits for devices across their life cycle.

The FDA in 2012 made moves toward such a system by establishing a National Evaluation System for Health Technology (NEST) to efficiently generate data for premarket approval of new devices and new uses of existing devices. Multiple stakeholder reports since have called for a federated virtual system using data from multiple sources, including unique device identifiers (UDIs), an approach the Pew Charitable Trusts is backing.

NEST should be operated by an independent coordinating center aimed at providing maximum value to an array of stakeholders including patients, providers, payers and device manufacturers as well as government, Shuren and Califf write. It could reduce the time and cost to gather evidence for premarket approval and could eliminate the need for some postmarket studies, they add.

NEST also could provide patients with better information about appropriate device use; inform physicians on selecting the right devices for particular patients, procedural outcomes and follow-up; help device makers understand how to mitigate risk across the device life cycle; and even suggest enhancements or other innovations.

In some cases, the need for FDA premarket review of device modifications could be eliminated, they say. It’s already piloting such an approach on some device types.

To learn more:
- here's the viewpoint