Mobile Medical Apps Come Under FDA Scrutiny

Source  |  Category: iPhone news  |  Posted on 19 July 2011

WASHINGTON -- The FDA has released proposed guidance for oversight of medical applications used on smartphones and other mobile devices -- but not to worry, the FDA is casting a pretty small net.

The agency emphasized that the guidance applies only to a subset of medical applications:

• Those that are used as an accessory to a medical device already regulated by the FDA (for example, an application that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet); or
• Those that transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices (for example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack)

"The FDA has a public health responsibility to oversee the safety and effectiveness of those mobile medical applications that present a potential risk to patients if they don't work as intended," Bakul Patel, policy adviser at the FDA's Center for Devices and Radiological Health (CDRH), said in a Tuesday morning conference call with reporters. However, he added, "we believe our approach doesn't cover the majority of mobile applications."

The FDA also has already cleared a handful of mobile medical applications, including smartphone-based ultrasound and mobile imaging applications for iPhone and iPad users, Patel noted.

The guidance basically calls for mobile medical apps to be subject to the same regulations as a similar nonmobile application would be (for instance, a mobile ultrasound device would be subject to the same regulations as a regular ultrasound device). That includes such things as labeling requirements, premarket submission requirements, and adverse event reporting requirements.

The FDA has not yet received any adverse event reports related to mobile medical devices, according to CDRH spokeswoman Peper Long.

Comments on the proposed guidance will be accepted for 90 days, the FDA said.