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.
Patel, who is the primary author of the FDA's final guidance on mobile medical applications released in September 2013, argued that the regulatory agency's oversight is "risk-based" and focused on a small subset of apps that present the greatest risk to patients. He said that under a "narrowly tailored approach" the vast majority of apps do not require active FDA oversight because they do not meet the definition of medical device under the federal Food, Drug and Cosmetic Act.
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