Lawmakers ask FDA to clarify proposed mHealth regulations

03/6/2013 | DOTMed.com

House Energy and Commerce Committee Chairman Fred Upton, R-Mich., and other Republican House members have asked FDA Commissioner Dr. Margaret Hamburg via a letter sent on March 1 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 if the FDA decides to regulate them as medical devices.

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