We have posted a couple of blogs regarding the FDA’s approval of mobile health applications, including the Mobile MIM and the MobiUS ultrasound imaging system. I came across a posting in medicalsmartphones.com that poses an interesting question. “How will the FDA regulate mobile health apps?”
The author ponders such questions as “How will the FDA choose which apps to regulate?” which leads to “How will they define what a medical device is?”
Also considered are the health claims that many medical applications make. “At what point will the FDA step in and send warning letters to app developers who are making these types of health claims?”
Technology is evolving so quickly, it makes one wonder how the FDA will be able to keep up… As the author states, ”By the time the FDA releases regulatory guidelines, they may be obsolete.”