Bakul Patel
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FDA Won't Regulate Medical Device Data Systems
Draft guidance published Friday by the U.S. Food and Drug Administration seemingly paves the way for smoother medical device interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements...
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Mobile Health: What Should Be Regulated And What Not?
With the mHealth industry anxiously awaiting the U.S. Food and Drug Administration's final draft of guidelines for mobile medical apps (expected by this fall), the talk at that particular panel discussion focused on what should be regulated and what shouldn't. Bakul Patel, a policy adviser for the FDA's Center for Devices and Radiological Health, pointed out that the market is flooded with apps – many of them harmless, but some of them potentially dangerous and in need of regulation.
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