Bradley Merrill Thompson, an attorney with an expertise in the FDA approval process for medical devices, is stating the Food and Drug Administration 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 – 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?
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“Any app that is used to transmit images to a medical facility requires FDA approval.” TO a medical facility… not FROM? Really important distinction.
Apple: Please, oh please, get rid of those blue light therapy apps…
I’m not going to demand that Apple remove the blue light therapy apps from the store (consider how many fart apps there are…).
I just wish there was a smarter categorization for the medical applications in the iTunes Store. There needs to be a section for REAL medical apps that does not include blue light therapy or sex position tips.
Yea, except fart apps at least follow through on their premise – to make you
laugh – they take you back to those younger years – and are quite effective
too! Most blue light therapy apps claim to make your acne go away and treat
forms of depression – and as we broke down in detail by looking at the
actual physics behind the apps – its false:
/20…
FDA already has forced out an app: “Within only a few weeks of submitting, we were contacted by the FDA and told that our app could not be on the app store (despite the fact that it was both free and labeled as “not intended for diagnostic use”) because it served as marketing for a device that was not cleared for marketing. We promptly removed it.” MobiHealthNews Interview with MIMVista 3/15/10
http://mobihealthnews.com/6932…
I wonder if the FDA makes this news public at all? And if they would ever contact Apple directly, instead of the company itself? Thanks for the comment Brian-