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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Posted on September 8, 2017September 8, 2017 by Jeannie Smith

Review the FDA’s recent Guidance document regarding RWE supporting regulatory decision making for medical devices here (PDF).

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The mission of the MDEpiNet Public Private Partnerships is to develop and implement innovative methods and national/international infrastructure for robust studies and surveillance to improve our understanding of medical device safety and effectiveness throughout device life-cycle. Our main objectives are to improve how medical device information is utilized throughout the life cycle of a device and to synthesize evidence on how medical devices are used throughout their life cycle. To accomplish our mission and objectives we have brought together an array of diverse stakeholders, including other government agencies, academia, health care industry organizations, and patient and consumer groups. These stakeholders bring to the table strategic resources, skills, and expertise from a variety of domains and requires participation from all . Read More...
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