THE US Food and Drug Administration has confirmed the creation of a new digital health operation to help manage the increasing proliferation of software as a medical device.
Currently the FDA is working on "what clinical validation looks like for software," according to a spokesperson, who added that the organisation was also working through responses to a consultation on draft guidance in the field.
Other work will cover artificial intelligence, advanced analytics, wireless devices, telemedicine, health IT and cyber security, according to a Regulatory Affairs Professionals Society report.
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