FDA has published an announcement about regulations regarding medical mobile applications.
The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, Read more »
*This blog post was originally published at ScienceRoll*