‘Software is not a medical device': FDA medtech chief battles for control of mHealth

Pitts to Shuren: 'Software is not a medical device'

The conversation got a bit heated this week as the House Energy & Commerce Committee’s subcommittee on Health sparred with FDA medical device chief Jeffrey Shuren over regulation of mobile medical and healthcare applications.

Shuren maintained that medical applications should fall under FDA purview regardless of their role in a primarily medical platform or on a mobile device, especially since more medical device makers are developing adjuncts to smartphones and tablets rather than building new technologies from scratch.

"Manufacturers don’t have to make the hardware anymore," Shuren told the subcommittee, chaired by Rep. Joe Pitts (R-Penn.). "That’s the way the world is changing."

The FDA in September released its final rule regarding medical applications for mobile platforms, largely taking a hands-off approach and focusing its oversight on a small subset of applications that it deemed risky enough to harm patients if not working as intended. That means the majority of healthcare apps won’t be regulated under the FDA’s charter, but those strokes were still too broad for some members of Congress who have put their support behind the SOFTWARE Act, seeking to further limit the FDA’s oversight of mobile healthcare technologies.

Challengers include participants in this weeks’ subcommittee meeting, some of them allies of Rep. Marsha Blackburn’s (R-Tenn.) SOFTWARE Act, which would restrict the FDA’s authority only to software that turns a mobile device into a medical device or software that complements medical technology. Blackburn’s SOFTWARE Act would keep the FDA out of mobile apps that the bill calls "clinical" or "health" software.

Shuren argued that new technologies that perform health and medical functions that have previously fallen under the FDA’s purview should get the same treatment as their predecessors, regardless of the platform, MobiHealthNews reported.

"The impact and the risk to patients is the same," he said. "Simply because they got smaller and I can pick it up and walk out of the room with it, doesn’t change the risk to the patients. Why for that reason alone would we treat it differently?"

Shuren got some support in the panel, namely from Rep. Henry Waxman (D-Calif.) who agreed that the rise of healthcare applications on consumer smartphones and tablets have complicated the issue of proper FDA regulation, but Rep. Pitts took a much more black-and-white approach to the problem.

"Software is not a medical device," he said in opening remarks for the panel discussion. "To regulate it as such, the FDA has said it will use discretion to decide which software to regulate. Except that no matter what Dr. Shuren may tell this committee here today, there is no guarantee that his successor won’t go back on this guidance tomorrow."

The FDA’s final mHealth rules feature some amount of flexibility in the agency’s authority to decide which applications merit extra attention, leaving developers with significant uncertainty in developing new products.

"While guidance is a valuable tool for the FDA, there is a significant limitation – certainty," Pitts said. "What stands today could change tomorrow."

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