MASSDEVICE ON CALL — As the Congressional hearing on the FDA’s oversight of medical apps came to a close, there were a number of insights into the so-called m-health world.
MobiHealthNews tallied the top 5 take-home lessons from the hearings, including estimates of the time it takes for a medical app to undergo FDA review and an estimate of when we’ll see the agency’s final medical app guidance.
Alongside discussions on the size of the medical app market and the annual rate of new applications, the FDA took time to dispel a rumor that the 2.3% medical device tax that took effect at the start of the year would affect iPhones and tablets.
Rumors of the "iPhone tax" reached the House Energy & Commerce Investigations subcommittee, where Republican members asked the FDA for an explanation.
"They would not be regulated as medical devices, therefore not subject to the medical device tax," FDA Center for Devices & Radiological Health director Christy Foreman told the panel.
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