According to a recent article on Pharmatimes.com, the FDA plans to issue guidance describing which medical apps on mobile devices will be subjected to FDA approval. With the advent of multiple new medical apps, the FDA plans to regulate mobile devices that perform jobs done by medical devices that already require FDA clearance or approval. According to Christina Foreman, director of the FDA’s device evaluation division, the goal of the regulation is to “foster technological innovation,” while ensuring that the apps are safe for the public. The FDA does not plan to regulate wellness apps, such as pedometers or heart-rate monitors. To read the full article, click here. Need help getting your medical device approved? Contact us at 317-899-9341.
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