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Latest Controversy Over FDA’s Health IT Regulatory Oversight Addressed By New Congressional Bill

FDA's Health IT Regulatory

You may have been following the news about the U.S. Food and Drug Administration’s ruling on September 23, 2013 for apps. DrinkerBiddle  Summarized the ruling of how the FDA issued a guidance (“Final Guidance”) explaining how medical device regulations will be applied to medical mobile applications (MMAs).

On February 11, Law360 reported that two senators announced that they had introduced legislation to restrict the U.S. Food and Drug Administration’s authority to regulate and tax mobile medical apps and other health care information technology as medical devices. The Senator’s argument is based on claims that the FDA’s current authority over such technologies is too broad. The Bill is S. 2007, the Preventing Regulatory Overreach To Enhance Care Technology Act, or PROTECT Act. This new Bill seems to be in response to many complaints that the FDA is over reaching its purview. 

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