After Multi-Day E&C Hearing Series Highlighting Uncertainty Created by Medical Device Taxes and Regulations, Obama Administration Finally Goes on Record with Pledge Not to Tax Consumers' Smartphones and Tablets

March 21, 2013

Christy Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological Health at the Food and Drug Administration, informed members and the public this morning that FDA’s policy on mobile medical apps will not include the regulation of consumers’ smartphones or tablets. She said: “Just as importantly as what our policy proposes is what our policy does not propose. It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities that exclusively distribute mobile medical apps, such as the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers. It 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. It would not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes. And, it would not apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.”

In July 2011, the Food and Drug Administration proposed regulating medical applications. This month, committee leaders wrote to FDA Commissioner Margaret Hamburg seeking more information on whether FDA intends to regulate smartphones, tablets, and mobile apps and whether it would trigger the 2.3 percent medical device tax included in the president’s health care law. This morning's hearing was the third in a three day series on potential regulations and taxes on smartphones, tablets, mobile apps, and other health information technologies.