HIMSS14: FDA Official Responds to Criticism Over Mobile App Approval Process

Responding to criticism that the U.S. Food and Drug Administration's regulatory approval process is lagging behind software development cycles, the FDA is standing behind the timeframes its takes the agency to review and approve mobile medical applications. Speaking at a HIMSS14 pre-conference symposium, FDA senior policy advisor Bakul Patel told the audience that in 80 percent of the cases the agency has met the statutory 90-day timeframe under the 510(k) process. 

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