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FDA Moves Toward Establishing a National Medical Device Evaluation Plan

1 December 2015 No Comment
Gregory Pappas, FDA National Device Evaluation Associate Director

A national medical device evaluation system is being established to further the mission of the Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration (FDA). The use of electronic data gathered in routine health care will enhance CDRH’s ability to evaluate device benefits and risks across the total product life cycle and successfully protect and promote public health. This evidence from clinical experience will allow for more rapid and accurate determination of safety and effectiveness issues. It will also facilitate the process of expediting patient access to important technologies. Establishing a national medical device evaluation system has become a strategic priority for CDRH for 2015–2016.

The national device evaluation system will collect device and patient-centric evidence from clinical experience from electronic health information such as electronic health records (EHRs), medical billing claims data, and data captured in procedure/device registries. Collaboration with data producers and users across the nation is essential to building this system. The core data strategy identified is linkage of clinical registries (national and international) to longitudinal data such as EHR and claims. The system will leverage and integrate with developing national resources such as PCORNet (EHRs) and Sentinel (claims data) and with CMS and State claims databases. The system also promotes the implementation of the unique device identifier (UDI) in claims data and electronic health records.

This robust infrastructure will help CDRH approve or clear devices more rapidly and appropriately; create a seamless process to transition products from pre- to post-market settings; generate continual feedback to enhance product development, innovation, and safety; and support patient health care needs.

The national medical device evaluation system evolved out of a vision for a medical device post-market surveillance system described in two FDA white papers. The initial report, “Strengthening Our National System for Medical Device Postmarket Surveillance,” was issued in 2012 and provides an overview of FDA’s medical device postmarket authorities and the current U.S. medical device postmarket surveillance system. The update to the report, issued in 2013, details the concrete steps that will promote more-efficient collection of better and more-timely data, which will help identify issues more quickly.

The Engelberg Center for Health Care Reform of the Brookings Institution convened a multi-stakeholder planning board to promote this vision. In February 2015, the planning board issued a report titled “Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System” that sets out the key steps for a national system for development, regulation, and effective use of medical devices, while supporting improvements in patient safety and health outcomes. The system, which will support the needs of the entire community of stakeholders, was rename an “evaluation system” with the release of the report “Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge the Clinical Care and Research” in August 2015.

MDEpiNet is a public-private partnership that produced this report and is working to build infrastructure for the national system and development.

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