FDA's Mobile Medical Apps Guidelines "Surprising"

By Katie Wike, contributing writer

The FDA’s mobile medical app guidelines allow a surprising amount of freedom and room for innovation

According to Government Health IT, the FDA probably had no idea the release of its mobile medical app guidelines would be seen as either sparking or killing innovation. “This is a really big deal for garage entrepreneurs, or whatever you would call them - people working in health institutions and even academics,” said Robert Jarrin, senior director of government affairs, Qualcomm. Morgan Reed, executive director and mHIMSS legal/policy task force chair for the Association for Competitive Technology, adds that for the first time in a long, long while, FDA “recognized that they aren’t going to tell us how to innovate.”

Whatever intent the FDA had in issuing its guidelines, they weren’t exactly what was expected. Jarrin and Reed recently outlined some of the more surprising parts in a virtual HIMSS briefing.

• Labeling will play a big part in whether or not a product is intended as a medical device. “It comes down to the intent of the person responsible for labeling the devices,” Jarrin said. He uses an analogy of an ink pen. If it is not stamped with any medical terms, it is clearly not a medical device. If somewhere in fine print, however, it is labeled as “sterile,” this implies the pen could be used for medical purposes.

• Footnote 27. Another interesting revelation in the guidance is found in footnote 27, regarding medication reminders. FDA gave a “very clear impression” it won’t be enforcing medication reminders on a platform or an app.

• Most apps, in fact, don’t even need regulation. “Many mobile apps are not mobile devices,” Jarrin added. “This is important.”  Even though some will meet the definition of mobile devices, they pose a low risk to the public, and the FDA won’t even regulate them. The FDA will only look at products that function as mobile medical devices and could pose a risk if they don't work as intended.

“There are issues that remain to be clarified by the FDA, including some on clinical decision software,” Jarrin said. “But overall, the guidance is chock full of anecdotes that provided better clarity.”

And when it comes to apps that fall in a gray area that appears undefined by the FDA, Reed said, “I think it’s really critical we understand that the regulatory discretion the FDA is providing here resembles an `I need to see progress’ and then we’ll make a decision down the road. But it’s also really important that we don’t treat this as a total free-for-all.”

Want to publish your opinion?
Contact us to become part of our Editorial Community.