Some developers of applications for mobile devices such as Apple’s iPad tablet computer are seeking FDA review of their products, HealthLeaders Media reports.
Seeking Approval
According to physicians, FDA has not provided guidance about which mobile health apps would need the agency’s approval and which would not. So far, few medical apps have undergone clinical trials or testing in academic medical centers.
Some developers of medical apps are pursuing FDA approval on their own. For example, AirStrip Technologies decided to classify its remote patient monitoring software as a medical device, making it subject to FDA safety and efficacy reviews. FDA cleared the app in July 2010.
Physician Input
Richard Katz — director of the cardiology division at George Washington University School of Medicine — said, “FDA is learning, or trying to figure this out. They’re trying to think of medical apps as either prescriptive or informative.”
Joseph Smith — chief medical and science officer at the West Wireless Health Institute — said FDA approval should be required for apps “that provide physicians with information that they use to make a diagnosis or treatment decision” (Clark, HealthLeaders Media, 3/4).
