Posts tagged ‘FDA’

July 22, 2014

Could health apps save your life? That depends on the FDA

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.


The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.


But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels. More clinical apps

The FDA is charged with keeping watch on the safety and efficacy of consumer health products. Lately, that includes more clinical apps as well as devices you might buy at the drugstore, like a home glucose testing kit.


“It’s these apps that the FDA says it will regulate,” David Bates of Brigham and Women’s Hospital and Physicians Organization told VentureBeat in June. These apps will have to go through the full 510(k) process,” he said.


Dr. Bates chaired a group to advise the FDA on how to review health apps for approval, and on how the FDA should advise developers.

“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” he said.


“The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” Bates said.

Bates believes the FDA wants to use a light regulatory touch when looking at new medical devices. “The FDA definitely wants innovation to continue in clinical devices,” he said. “In general the FDA knows that the vast majority of apps are just informational.”


The FDA’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.


Health apps go mainstream

The big software companies (Apple, Google, and Samsung) have brought attention to, and lent credibility to, apps and devices that do more than count steps. These companies are building large cloud platforms designed to collect health data from all sorts of health apps and devices.


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October 15, 2013

FDA clarifies its position on mobile medical apps | L’Atelier: Disruptive innovation

Two years after publishing a first draft,the FDA has now come up with ‘final guidance’, comprising a list of recommendations in the field of m-health apps. Given the legal void to date and the confusion brought about by dealing with issues on a case by case basis, the United States health regulatory authority is trying to bring greater clarity to a market which numbers over 40,000 apps and is estimated to be worth some $26 billion by 2017. The uncertainty surrounding the regulatory issues has been slowing down the growth of this market, despite the fact that the Obama administration is strongly encouraging innovation in order to combat deficiencies in medical care and make hospital budgets stretch further.

Apps to be regulated like traditional medical instruments

The FDA is focusing its recommendations on two types of software applications, whose use approximates to that of traditional professional medical equipment. Firstly this means applications developed to be used as an accessory to a regulated medical device, e.g. an app that enables a doctor to make an analysis or diagnosis using a tablet or to send/receive a patient’s medical information via a mobile device. The second group includes any app that actually transforms a mobile platform into a regulated medical device, a clear example being the AliveCor app which enables a mobile device to create electrocardiograms. These two categories are to come under FDA regulatory oversight and such apps will be assessed for compliance according to the same criteria as for any other medical equipment. By contrast, the FDA has no intention of regulating fitness or wearable technology apps such as activity tracker Fitbit andonline calorie counter and diet plan app MyFitnessPal. Explained Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health: “We wanted to achieve the right balance and include only those applications which could potentially harm the user.”

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From Pharmaceutical Industry digital vision