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FDA drafts mobile medical app regulations

BREAKING: The US Food and Drug Administration (FDA) has issued a draft guidance on which mobile medical apps should be regulated as medical devices. The guidance includes a laundry list of apps that would fall into the regulated group along with a handful that would not.

MobiHealthNews spent yesterday parsing the FDA’s 30-page guidance document, which the agency made public this morning. In anticipation of the announcement, MobiHealthNews also interviewed FDA policy advisor Bakul Patel and the FDA Director of the Center for Devices and Radiological Health Dr. Jeffrey Shuren for more perspective.

Read full article here. . .