| Regulatory Issues for Wireless Health Companies: How to Know What Regulations Apply, When They Apply, and What That Means For Product Development. CommNexus. In this event, the panel will explore various issues with FDA and FCC regulation and certification that arise with the convergence of health care and wireless technologies. The panel will explain the tripping point for when a device would require FDA authority, high level strategy for entering FDA space, examine places where challenges with FDA regulation exist, and provide insight into the successful completion of the process and some of the highs and lows involved. Also discussed will be issues raised by the incorporation of off the shelf radios into medical devices and how that can effect FCC certification. See http://www.commnexus.org/programs/special-interest-groups/event_20090928.php |
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