Lawmakers Clash Over Mobile Medical App Regulation

Some lawmakers are attempting to put the kibosh on the Food and Drug Administration’s (FDA) plan to regulate some mobile medical apps.

The House Commerce Committee’s Subcommittee on Health held an informational hearing on Nov. 19, 2013 to discuss the FDA’s recent guidance document on mobile medical applications, including what constitutes a medical device for purposes of regulation. Ambiguity in the scope of that definition has been a source of concern for some lawmakers, leading to new legislation that seeks to further clarify the FDA’s intentions and restrict some of its regulatory authority. Called the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, the bill must still be evaluated by both the House and Senate. In his opening statement during the hearing, subcommittee chairman Joe Pitts (R-PA), said that while patients and industry representatives agreed that the FDA’s involvement and guidance was a positive, too much ambiguity exists around the definition of a medical device. Meanwhile, Rep. Frank Pallone (D-NJ), felt encouraging innovation is important, but so was shepherding technologies that were safe for patients.