The House of Representatives Committee on Energy and Commerce (the “Committee”) is set to hold a three-day series of hearings next week regarding regulation of medical device mobile applications. The hearings follow a March 1, 2013 letter from the Committee to Food and Drug Administration (“FDA”) Commissioner Dr. Margaret Hamburg. In the letter, the Committee acknowledges the growth of the health-related and medical device mobile application market and how such products are regulated. The Committee also expresses concern that, in the face of this growing industry, FDA’s current guidance and outstanding questions regarding the tax implications of these products create a lack of clarity for industry that could stifle innovation.

Under the Food, Drug and Cosmetic Act (“FDCA”), the FDA has authority to regulate medical devices. In mid-2011, the agency issued draft guidance on how medical device mobile applications would be regulated. The Committee expresses concern that FDA has received many public comments on the topic but has not held any public workshops or finalized its draft guidance.

The Committee requests that Dr. Hamburg provide written responses to questions regarding the following topics:

  • FDA’s timeline for finalizing the draft guidance
  • FDA analysis regarding the effect of the medical device excise tax on smartphones
  • Whether use of a mobile device will be a factor when FDA chooses to regulate a particular product as a mobile device
  • The number of mobile medical applications for which marketers have sought FDA approval before entering the market and the after-market experience regarding these applications