The FDA is moving ahead with plans for the National Evaluation System for Health Technology (NEST) as one of its top CDRH priorities this year.
The agency has been working with the Medical Device Innovation Consortium (MDIC) under a $3 million FDA grant to create and staff the NEST program, which will integrate data from clinical registries, electronic health records, and medical billing claims to gather more comprehensive evidence of medical device safety and effectiveness.
High-quality evidence at lower cost and in less time could eliminate the need for FDA premarket review of some device modifications because of more timely and informative routine data collection, according to CDRH Director Jeffrey Shuren.
NEST will get its base funding from the private and public sectors and users will pay for access to data and analysis from participating sources. An independent coordinating center will be responsible for driving standardization for core data elements, data quality, development of advanced analytics and creating data use agreements, Shuren said.