There are now more than 100 mobile medical apps registered with or cleared by the FDA as medical devices, according to MobiHealthNews' just-updated report, aptly named: The 103 FDA Regulated Mobile Medical Apps.
When we first published our extensive round-up of FDA regulated mobile medical apps in December 2012, we found 75 apps in FDA's databases. This time around we added those that received clearance in 2013 as well as a handful of Class I devices we weren't able to find in time for our last report. By our count about two dozen mobile medical apps either registered with the FDA as Class I devices or secured clearance as a Class II device.
No mobile medical apps sought premarket approval as Class III devices in 2013, which was no surprise. If you recall, during the third day of congressional hearings on the FDA's role in regulating mobile medical apps back in March, FDA's Christy Foreman, who serves as the Director of the Office of Device Evaluation at the Center for Devices and Radiological Health, said during her testimony:
"If we move up to the next level -- Class III -- that requires a premarket approval application. To date, we have not found a mobile app that would fit under that bucket," Foreman said. "Not saying that in the future it wouldn't be possible, but we have not seen that yet."
Actually, the FDA did once clear a mobile medical app as a Class III device -- 11 years ago -- way back in 2002.
In January of that year Micromedical secured clearance for its PocketView ECG software-- a modification of the already cleared Cardioview 3000 software -- that would now allow the 12 lead simultaneous ECG cable to be linked to commercially available (off the shelf) personal digital assistants (PDA) running the Windows CE operating system. Based on our research, this mobile medical app has the lone distinction of having a Class III clearance.