According to the new report 2016-2017 “Strategic Priorities Center for Devices and Radiological Health”, the FDA’s www.fda.gov “ Center for Devices and Radiological Health’s” (CDRH) goal is to develop a National Evaluation System for Medical Devices. High costs and inefficiencies of data generation in clinical trials have created disincentives for innovators to study their technologies in the U.S and then bring their products to this country.
Limitations on current post market surveillance tools, such as passive reporting also constrain CDRH’s ability to rapidly address safety concerns. A national medical device evaluation system would be able to help strike the right balance between premarket and post market data collection and handle the vast amount of information generated as part of routine healthcare and/or data from patients using monitoring devices.
Access to electronic clinical generated could be used to identify safety signals and support risk-benefit analyses when data quality is ensured and advanced analytics are applied. Real world evidence in the future will be able to support regulatory decision making across the pre-and-post market continuum.
Go to www.fda.gov/MedicalDevices/default.htm click on Spotlight for the report 2016-2017 “Strategic Priorities Center for Devices and Radiological Health”.