Committee Leaders Seek More Information on FDA Regulation of Smartphones, Tablets and Apps

March 4, 2013

Regulating Smartphones as Medical Devices Could Affect Growth and Innovation and Trigger Obamacare Device Tax 

WASHINGTON, DC – Republican leaders of the House Energy and Commerce Committee last week pressed the Food and Drug Administration to provide insight on how they plan to regulate mobile medical applications. Committee leaders are concerned that FDA may subject more smartphones and mobile apps to regulation as medical devices, which could result in their being taxed under Obamacare and harm the innovation and economic benefits of the U.S. mobile marketplace.

In a letter to FDA Commissioner Margaret Hamburg, the leaders wrote, “With the growth of the smartphone and tablet market in the United States, the use of applications to monitor health information on these devices has also increased.  Some medical applications are used to monitor health information, like diet and fitness data.  Other applications can be used to monitor chronic conditions such as diabetes or high blood pressure.”

In July 2011, the FDA proposed regulating mobile medical apps that were either used as an accessory to a medical device already regulated by the FDA or transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices, presuming the manufacturer marketed the product for its medical uses. Today, the members asked whether this guidance would be changed or finalized.

Citing the lack of clarity, the members warned, “this could affect the growth and innovation in this market.” In addition, “it raises the possibility that these companies would also be subject to new taxes under the PPACA.”

Members requested the FDA clarify its intentions by March 15, 2013.

To view a copy of the letter, please click here.

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