FDA taking ‘very light touch’ in smartphone and digital device regulation

Bakul Patel, the Agency’s Associate Director for Digital Health, told Bloomberg that most wearable devices such as the Apple Watch and applications for smartphones have a long road ahead of them before the FDA steps in with heightened regulation.  “We are taking a very light touch, an almost hands-off approach,” Patel said.  “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

In January 2015, the agency said it would avoid regulating most general wellness devices, including wearables like Fitbit’s exercise trackers.  The following month, the FDA released its guidelines on regulating mobile applications, sparing fitness-tracking and other wellness-related products for its scrutiny while pledging to give technology used for diagnosis, treatment and prevention more of a once-over.

Part of how the agency will evaluate new mobile products depends on how the device is marketed, Patel told Bloomberg.  Products that help doctors make medical decisions will require more oversight, as so will emerging technologies that diagnose illnesses or offer treatment recommendations.  “We are focusing only on the higher end of technology,” Patel said, as quoted by Bloomberg.  “What are the benefits to public health against the risks to public health?  We always try to balance that.”

But not everyone is convinced that the FDA is capable of regulating the new devices.  The FDA’s $4.5 billion annual budget is a quarter of the $18 billion Apple roped in during it’s most recent quarter, and the Agency and other regulatory bodies might not have the resources and staff to handle oversight of a fast-changing industry, Malay Gandhi, managing director of Rock Health, told the news outlet.  “I worry that there are going to be companies that are skirting the rules,” he said.  “We have to see the enforcement, otherwise it creates a very uneven playing field between companies that are acting ethically and those that aren’t.”

And the FDA is not the only Agency taking a hard look at new digital devices.  In February 2015, the FTC cracked down on two companies producing smartphone apps making questionable medical claims.  Melapp said its smartphone diagnostic device used an uploaded picture to predict a patient’s risk of melanoma and aid in early detection, while Mole Detective claimed it had the “first and only app” to screen from symptoms of melanoma on the phone.

REFERENCE:  Fierce Medical Devices; 30 MAR 2015; Emily Wasserman

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