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Silicon Valley struggles to speak FDA’s language

BY MATTHEW PERRONE AP Health Writer WASHINGTON — From Apple’s new smartwatch that tracks heartbeats to contact lenses that measure blood sugar — Silicon Valley is pouring billions into gadgets and apps designed to transform health care. But the tech giants that have famously disrupted so many industries are now facing their own unexpected disruption: regulation.

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AdvaMed says FDA proposed rule would result in more PMAs

The device industry is awaiting the final FDA rule on medical device classification procedures, and will be combining it with the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to…

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The Sunshine Act: Promising Clarity & Providing Confusion

The logic behind the Sunshine Act says that providing clarity on any money that pharma and device makers pay to doctors and hospitals will reduce the occurrence or appearance of corruption. . The idea is that by making those payments a matter of public record makes it undesirable for companies to try to influence medical experts.

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