FDA Outlines Safety Testing For Telehealth Medical Devices

Law360, New York (August 13, 2013, 5:44 PM EDT) -- The U.S. Food and Drug Administration on Tuesday finalized guidance for minimizing the risks associated with medical devices that use wireless technology, the latest notable development for the fast-growing telehealth field.

In a sign of the document’s significance, the FDA took the somewhat unusual step of trumpeting the guidance’s release in a blog post. Bakul Patel, a senior policy advisor at the FDA, praised the promise of untethered devices but also raised the spectre of glitchy radio frequency signals delaying the transfer of time-sensitive information or...
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