As promised, FDA has issued draft guidance laying out plans for the oversight of mobile applications used for medical or healthcare purposes.
In a press release dated July 19, the administration explained that the proposed guidelines will only impact applications that “are used as an accessory to a medical device already regulated by the FDA” or “transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices”. Examples cited by FDA include an app that allows health care providers to make a diagnosis by viewing a medical image on a smartphone or tablet and an app that allows a smartphone to function as an ECG machine.
"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," CDRH director Jeffrey Shuren said in a statement. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."
The public now has 90 days to offer comment.
Will this steer developers away from medical apps? Please share your thoughts below.