The committee wants to know if regulation of the apps means they would fall under the health care reform law’s excise taxes on medical devices, and asks for responses to five questions by March 15.
The FDA has noted it does not intend to regulate an app as a device unless it is designed to transform a device into a regulated medical device by using sensors or other tools that can make it a diagnostic tool, the committee noted in its letter. “Although FDA’s announcement on medical applications focused on the ‘intended use’ of the application when determining whether it should be regulated as a medical device, we are concerned about the potential of ‘actual use’ becoming a factor in the future. Last year, members on this committee wrote to you because draft guidance issued by the FDA on Commercially Distributed in Vitro Diagnostic Products indicated that ‘actual use’ would be a factor in your analysis of ‘intended use.’ If FDA decides to take a similar approach in its final guidance with medical applications, this could affect the growth and innovation in this market.”
If FDA determines that certain mobile apps are medical devices, it raises the possibility that they would be subject to the new taxes, according to the committee, which seeks clarification on these questions:
* When will the FDA issue final or updated guidance with respect to the July 19, 2011, request for input on its oversight approach for mobile medical applications designed for use on smartphones or other mobile computing devices?
* Has the FDA discussed, prepared, or analyzed the effect of the medical device tax on smartphones (as well as tablets or similar devices) or the creators or distributors of applications for those products? If so, please provide all documents analyzing or relating to this issue.
* 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?
* How many medical mobile 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?
The full letter is available here.