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FDA issues draft guidance on reviewing health-care mobile apps

If you were worried that the U.S. Food and Drug Administration will include calorie counters as health-care mobile apps that need agency review, you can breathe easy.

However, if a calorie counter is part of a health-care mobile app that also collects blood glucose readings to help manage diabetes by calculating pre-meal insulin dose (Bolus) or Basal adjustments, then it will need agency oversight.

That’s the tricky line that the agency is trying to navigate in this brave new world of health-care 2.0.

The FDA issued draft guidance Tuesday that outlines how it intends to regulate mobile medical apps and repeatedly stressed that the final regulations would only address a small subset of mobile medical apps. The FDA does not intend to stymie mobile apps development or regulate how people use smartphones, said Bakul Patel, policy adviser at the Center for Devices and Radiological Health.

In a conference call with reporters, he said that the goal is to balance innovation with patient safety.

“FDA encourages this exciting development of new applications that can make health care better,” Patel said. “The FDA also has a public health responsibility to oversee the safety and effectiveness of those mobile medical applications that pose a risk to patients if they don’t work as intended.”

The agency will allow public comment starting tomorrow through Oct. 18.

To date, the agency has cleared a handful of medical apps, including this radiology app from Mobile MIM.

The guidance documents are available here.

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