Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction.
James Kendrick from JkOnTheRun spoke with Thompson, where he stated the following:
The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.
By “various app stores,” Thompson is likely referring to the App store [Apple], Palm App Catalog [Web OS], App World [BlackBerry], and the Android Marketplace [Android OS].
Thompson also mentioned that although some medical app developers are attempting to get FDA approval, the specific apps required to do so still remains murky. Concurrent with Thompson’s above statement, earlier this year Health Canada, a body similar to the FDA, approved an imaging app, Resolution MD Mobile, for diagnostic imaging use by Canadian clinicians.
Another question this type of monitoring raises is: Will the FDA ever “force out an app?” We have documented before how there are currently apps taking advantage of consumers, such as the so-called “blue light therapy apps.“ We were able to show through data how these apps are distorting the truth, but is it enough for the FDA to get involved?
*This blog post was originally published at iMedicalApps*