> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDRH Top Priority is National Device Evaluation System
- URL: https://www.fdaweb.com/cdrh-top-priority-is-national-device-evaluation-system/
- Published: 2016-01-13T12:00:00.000Z
- Updated: 2026-09-15T02:27:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134424

> CDRH has announced its three [strategic priorities](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf?ref=fdaweb.com) for 2016-2017 — establish a National Evaluation System for medical devices; partner with patients; and promote a culture of quality and organizational excellence.  
>  
> The Center says the national medical device evaluation system will “build upon and leverage the vast amount of information and knowledge created every day as a part of routine health care or generated at home, such as patients using monitoring devices – what we call ‘real-world evidence.’” It says that having access to large amounts of electronic clinical data being generated and collected today “can 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. To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for regulatory decision making, that data flows seamlessly between systems, and that unique device identifiers (UDI) are routinely incorporated into electronic health information.”  
>  
> The Center explains that the new system would comprise electronic health information (EHI), registries, and medical billing claims. It would also access data from the agency’s Sentinel (currently claims data) initiative. “It would be developed through strategic alliances between disparate data sources and advancing the UDI adoption in EHI, data quality standards, interoperability, and methods development,” the strategic report says. “The National Evaluation System would be operated by a public-private partnership and governed by a board with representatives from the various stakeholder communities in the medical device ecosystem, including government.”  
>  
> CDRH says that by the end of 2016, Center staff should have access to 25 million electronic patient records (from national and international clinical registries, claims data, and e-health records) with device identification. And by the end of 2017, staff should have access to 100 million such records.