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]. Read more »
*This blog post was originally published at iMedicalApps*