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FDA Entrepreneur’s Workshop

February 1, 2018 @ 3:00 pm - 5:00 pm

This session will provide an overview of the U.S. Food and Drug Administration’s (FDA’s) regulation of medical devices, covering development of regulatory premarket strategies, the approval and clearance processes, and postmarket safety and recalls. As part of this overview, the presenters will also cover timely subjects such as 3D printing of medical devices and direct-to-consumer tests for genetic risk information. The digital health component will include a discussion of the specific requirements for medical device software and review the current status of the 21st Century Cures Act as it relates to the regulation of medical device software, an evolving field that encompasses wearable technologies, health IT and cybersecurity.

Thu, February 1, 2018
3:00 PM – 5:00 PM EST
The Chesterfield
701 West Main Street
Durham, NC 27701

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The Chesterfield
701 West Main Street
Durham, NC 27701
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