Emergo says mobile medical apps should soon see some guidance.
"Manufacturers have thus far received little official guidance from FDA regarding how CDRH would handle mobile medical applications. Although some medical devices incorporating mobile applications have already been cleared by the FDA—GE’s Pocket Viewer, Airstrip Technologies’ Airstrip, Mobisante’s MobiUs and MIM Software’s Mobile MIM, for example—no high-level evaluation criteria have yet been issued by the regulator regarding these products."
FDA has not determined whether PMA or 510(k) pathways are appropriate.However, Brian Dolan at mobihealthnews says FDA has already been regulating apps, and he has 10 product examples to prove it. Below are a few of the apps Dolan identified as having met FDA scrutiny.