FDA Center for Devices and Radiological Health’s www.fda.gov goal is to establish a “National Evaluation System for Medical Devices” according to the “Center for Devices and Radiological Health (CDRH) 2016-2017 Strategic Priorities Report.”
According to the report, high costs and inefficiencies related to data generation in clinical trials has created disincentives for innovators to research their technologies in the U.S and then ultimately bring their products to this country.
A national medical device evaluation system leveraging real-world evidence would help FDA more efficiently strike the right balance between premarket and post-market data collection. The system would also facilitate patient device access and quickly identify safety signals by assuring timely and robust post market data collection.
Access to large amounts of electronic clinical data being generated today could be used to identify safety signals and support risk-benefit analyses when data quality and advanced analytics are applied.
Real world evidence in the future would be able to support regulatory decision making across the pre- and post-market continuum. Systems need to be developed to ensure that data quality is appropriate and sufficient for regulatory decision making, data needs to flow seamlessly between systems, and unique device identifiers need to be routinely incorporated into electron health information.
The National Evaluation System for Medical Devices would use real-world evidence supported by electronic health information such as EHRs, registries, and medical billing claims where device identifiers have been incorporated. The system would leverage and integrate data from PCORnet, Sentinel Initiative, plus national and international registries.
The system would be operated by a public-private partnership and governed by a board with representatives from the stakeholder communities in the medical device ecosystem including government.
Go to www.fda.gov/MedicalDevices/default.htm then click on CDRH Strategic Priorities and Updates to view the report titled “2016-2017 Strategic Priorities”.