FDA Strikes Agreements to Use Device Registries

The FDA has reached agreements with 14 device registries as part of its ongoing effort to harness real-world evidence to evaluate the performance of medical devices.

CDRH Director Jeffrey Shuren reiterated in an interview with FDAnews Device Daily Bulletin that using real-world evidence, including data gathered by the National Evaluation System for Health Technology (NEST), is one of his top priorities in 2017.

The FDA has also awarded $3 million in seed funding to the Medical Device Innovation Consortium to establish NEST to collect and analyze data from clinical registries, electronic health records, medical billing claims, data transmitted from devices, and other sources throughout the medical device life cycle.

Currently, NEST is seeking nominations and applications for inaugural members of its governing committee. The governing committee will provide strategic oversight and leadership, and will be supported by an executive director who will provide operational leadership to staff and ongoing working groups. Committee members will serve up to 3-year terms.