martes, 20 de septiembre de 2016

CDRH Industry: New Report on The National Evaluation System for health Technology: Priorities for Effective Early Implementation

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Establishing a National Evaluation System for health Technology (NEST) is one of CDRH’s 2016-2017 strategic priorities.  NEST is a collaborative system that leverages real-world evidence from many different sources—including clinical registries, electronic health records and medical billing claims— to better understand how medical devices perform. Harnessing this information will contribute to regulatory decisions, promote device innovation as well as provide timely and meaningful information directly to patients and their health care providers.   
On September 20, 2016, Duke-Margolis Center for Health Policy published the report, The National Evaluation System for health Technology: Priorities for Effective Early Implemenation. This is the third in a series of reports from the Planning Board to support NEST development and outline expectations for an independent, transparent Coordinating Center, which will manage efforts that guide NEST implementation.  The first Planning Board report issued in February 2015 set out key steps towards developing a national evaluation system and identified the need for a Coordinating Center.   In April 2016, a second Planning Board report, Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System further outlines expectations, roles and responsibilities for the Coordinating Center.
Today’s Planning Board report provides specific governance and oversight recommendations for the Coordinating Center, as well as identifies priority areas and projects to support medical device evaluation and surveillance.  The FDA supports the development of a Coordinating Center and continues to fund projects that will generate real-world evidence on device performance.  These are important steps toward developing and implementing a National Evaluation System for health Technology.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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