Foreman, who is Director of the Center for Devices and Radiological Health’s Office of Device Evaluation, stated that the FDA has no intentions of regulating the sales or “general consumer use” of smartphones and tablets. Furthermore, distributors of mobile medical apps such as the iTunes App Store will not be considered medical device manufacturers, according to her testimony.
“FDA’s proposed mobile medical apps policy would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA,” Foreman stated at the hearing.
She further explained that mobile medical app developers will not be required to seek FDA re-evaluation for minor or iterative changes to their products, and that mobile medical apps functioning as electronic health records or personal healthy record products.
Based on Foreman’s comments, it appears that only a small, tightly-defined group of mobile medical apps will fall under FDA regulation as medical devices—as well as bear liability for the US Medical Device Excise Tax (MDET). Although the FDA has yet to publish its final rules on mobile medical technology regulation, developers now have a better idea of which apps the agency will not regulate.
REFERENCE: EMERGO GROUP – 26 MARCH 2013