Legislators seek clarity on FDA oversight of mobile medical apps

With the growth of the tablet and smartphone market, U.S. House of Representatives Energy and Commerce Committee members requested clarity from the Food and Drug Administration (FDA) on its regulatory authority over mobile medical applications, and whether mobile device manufacturers could be subject to excise taxes pursuant to the Patient Protection and Affordable Care Act (PPACA).

In a March 4 letter to FDA Commissioner Margaret Hamburg, the committee asked for more information on the status of a July 2011 draft document that sought public input on its oversight approach. In the draft, oversight encompasses technology that serves as an accessory to a medical device already regulated by the FDA or a transformation of a mobile communications device into a regulated medical device through use of attachments, sensors or other devices. The FDA said makers of mobile devices would not be considered medical device manufacturers unless they marketed the product for medical use, according to the letter.

However, the issue of “intended use” versus “actual use” in the regulatory scope of the FDA was an issue for the committee.

“Last year members on this committee wrote to you because draft guidance issued by the FDA on commercially distributed in vitro diagnostic products indicated that ‘actual use’ would be a factor in your analysis of ‘intended use,’” the committee wrote, adding that if the FDA takes a similar approach in its final guidance with medical applications, it could affect the growth and innovation in the market. Also, the legislators expressed concern that makers of smartphones, tablets or mobile medical apps could be subject to new excise taxes under the PPACA.  

The committee then asked the FDA to provide both written answers and briefings to the following four questions by March 15:

1. When will the FDA issue final or updated guidance with respect to the July 19, 2001, request for input on its oversight approach for mobile medical applications designed for use on smartphones or other mobile computing devices?
2. Has the FDA discussed, prepared or analyzed the effect of the medical device tax on smartphones or the creators or distributors of applications for those products? Is so, please provide all documents analyzing or relating to this issue
3. Will the actual use of a smartphone, tablet or app be a factor in whether the FDA chooses to regulate the device or app as a medical device? Has it been a factor in any analysis by FDA already completed?
4. How many mobile medical apps have sought approval from the FDA before entering the market? What was the processing time for each of these apps? How many mobile medical apps have been subject to oversight by the FDA after introduction to the market? How many apps have either been changed or removed from the market by FDA oversight, and why?