FDA is urged to clarify proposed mHealth regulations

03/6/2013 | DOTMed.com

House Energy and Commerce Committee chairman Fred Upton, R-Mich., and other Republican members sent a letter asking FDA Commissioner Dr. Margaret Hamburg to provide clarity on the agency's proposal to regulate certain mobile health applications. The legislators expressed concern that manufacturers of mHealth apps, smartphones and tablets could be subjected to the 2.3% tax under the health care law should the FDA decide to regulate them as medical devices.

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