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# Paper Outlines Device Evaluation System Coordinating Committee
- URL: https://www.fdaweb.com/paper-outlines-device-evaluation-system-coordinating-committee/
- Published: 2016-04-04T12:00:00.000Z
- Updated: 2026-09-14T20:52:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135275

> A Duke-Margolis Center for Health Policy [white paper](https://healthpolicy.duke.edu/files/2016/03/med-device-report-web.pdf?ref=fdaweb.com) outlines the business practices of a proposed independent coordinating center that would guide the future development and implementation of CDRH’s national evaluation system for medical devices. Establishing the device evaluation system is a top [strategic priority](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf?ref=fdaweb.com) for 2016-2017\. The Center says the 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.”  
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> Such real-world evidence in the future will be able to support regulatory decision making across pre- and post-market phases. “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,” CDRH says.  
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> The white paper was funded by FDA and included substantial input from senior CDRH officials, including Center director **Jeff Shuren**. The proposed coordinating center would “provide governance, coordination, and standardization to drive down the time and cost of generating evidence on medical devices, while increasing the accessibility and usability of real-world data,“ the paper says. “The coordinating center should ultimately be responsible for creating opportunities for better and more efficient evidence generation and evidence sharing through coordinating and facilitating effective use of the coordinating center’s methods partners’ expertise and the network of data partners by diverse public and private stakeholders.”  
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> The paper also says the coordinating center should “work closely with stakeholders across the device ecosystem to assess their needs, and facilitate demonstration projects that leverage current activities to more effectively meet those needs while also strategically building a system focused on the reusability and interoperability of data, network linkages, and tools. The coordinating center should continually engage stakeholders to understand their emerging needs and monitor innovation to ensure that \[the evaluation system\] is flexible and adaptable.  
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> Additionally, the paper recommends that the coordinating center be instituted as a public-private partnership with both public and private representation on its governing board. “While the coordinating center would not have explicit regulatory authority, it would be possible for FDA’s authorities to work through the coordinating center in a similar way drug surveillance activities are conducted under the Sentinel System,” it says. “Another potential model is the Medical Device Innovation Consortium (MDIC), which works in partnership with FDA to improve regulatory science. Ideally, non-governmental organizations will voluntarily seek to partner with the coordinating center based upon simplified access to high-quality services and resources that facilitate the expedited execution of high quality research and public health evidence development activities more effectively and at a lower cost than the current model.”