House Republicans on the Communications Subcommittee said they're wary that...

posted to the subcommittee’s website. FDA classification of cellphones with health applications as medical devices could subject entrepreneurs to lengthy clearance or approval requirements, the memo said. If the agency considers cellphones with health applications to be medical devices it could have the negative result of stalling innovation, investment and job creation and “ultimately impact the larger wireless ecosystem,” according to the memo. The comments came ahead of Tuesday’s 10 a.m. Communications Subcommittee hearing in 2123 Rayburn. Robert Jarrin, Qualcomm senior director-government affairs, plans to say he’s particularly concerned that the FDA’s failure to release its final guidance on mobile medical applications “has created uncertainty among countless budding entrepreneurs and large corporations that fear the prospect of facing FDA regulation,” according to his advance testimony. Jarrin will tell lawmakers that the guidance should be promptly finalized, include specific examples of mobile devices that would not be subject to regulation, provide more clarity on mobile health terms, and coordinate its efforts through a dedicated FDA mobile health office, among other suggestions. George Ford, chief economist at the Phoenix Center, is also set to tell lawmakers that FDA regulation of mobile health applications could slow the rate of innovation and growth of the wireless industry, according to his written testimony. Jonathan Spalter, chairman of Mobile Future, expects to tell lawmakers there’s a “clear cut need for some degree of oversight over clinical treatment,” but mobile health innovators need better guidance on which agencies from which they must receive federal approval, according to his written testimony. Spalter plans to point to the confusion, duplication and jurisdictional overlap of medical device regulation from the FDA, the FCC, the FTC, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of the National Controller. There must be a clear definition of when mobile health devices and applications are subject to federal regulation, said Spalter’s testimony. And the government should ensure a speedy approval process for those devices and applications that are subject to regulation so to “keep pace with emerging technology and meet consumer demand,” according to his testimony. Benjamin Chodor, CEO of Happtique, a provider of mobile health services, plans to tell lawmakers that medical device excise taxes should not apply to cellphones, tablets or mobile health apps, according to his written testimony. Such taxes would slow innovation by placing “burdensome costs on app developers in a new and growing market,” he expects to say.