A Food and Drug Administration official assured the House Commerce Oversight...
A Food and Drug Administration official assured the House Commerce Oversight Subcommittee Thursday during a hearing that the administration is not targeting cellphones and tablets as medical devices subject to a federal excise tax, just because they're used for medical…
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apps. “FDA’s proposed mobile medical apps policy would not regulate the sale or general consumer use of smartphones or tablets,” said Christy Foreman, director of the FDA’s Office Of Device Evaluation Center For Devices And Radiological Health. “FDA’s proposed mobile medical apps policy would not consider entities that exclusively distribute mobile medical apps, such as the owners and operators of the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers. FDA’s proposed mobile medical apps policy 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.” Foreman provided the government’s response to questions raised during a Communications Subcommittee hearing Tuesday (CD March 20 p1). “I have seen that in today’s testimony the FDA is now definitely saying: No, we will not regulate the general sale of smartphones or tablets,” said Subcommittee Chairman Tim Murphy, R-Pa., in his opening statement at the hearing. “I thank the FDA for providing certainty on this matter.”