FDA Regulation of Mobile Health Devices


Software has increasingly become an integral part of healthcare, whether through incorporation into medical devices, as a stand-alone system that practitioners use to make clinical decisions, or as a means for transmitting and storing medical records.

The federal government has supported the growth of mobile health technology through various incentives and directives, but the regulatory landscape remains unsettled. This presentation will review the Food and Drug Administration’s approach to medical software regulation by providing a brief history, the FDA’s current regulatory position, and where we anticipate the FDA will head in light of recent Congressional prodding.


Duration: 56:10
Publisher: Online Tech
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