FDA Issues Final Guidance for Mobile Medical Apps

The US Food and Drug Administration (FDA) announced that it has issued final guidance for developers of medical mobile apps – user-friendly software programs that run on mobile communication devices, such as smartphones and tablet computers.

The guidance reveals that the federal agency will focus regulation on a small subset of medical apps that present a greater risk and will exercise discretion for the majority that pose minimal risk to consumers.

The FDA has powers under the US Federal Drug & Cosmetic Act (FD&C Act) to oversee the safety of drugs, foods, cosmetics and medical devices.

In the guidance, the agency explains that many mobile apps are not medical devices (that is, they do not meet the definition of a device in the FD&C Act), and so it does not regulate them.

Also, while some mobile apps may meet the definition of a medical device because they pose a lower risk to consumers, the FDA intends to “exercise enforcement discretion over these devices,” meaning it will not enforce requirements under the FD&C Act.

Mobile medical apps market growing fast

Mobile medical applications (apps) perform the same functions as traditional medical devices. For instance, they help consumers manage their own health and wellbeing, promote healthy lifestyles, and access information where and when they need it.

These personal tools are emerging almost as fast the mobile devices they run on, and their impact on self-monitoring is transforming health.

Mobile medical apps also have the potential to transform healthcare by helping doctors diagnose patients with potentially life-threatening illnesses outside of traditional health care settings.

Some currently available apps can diagnose abnormal heart rhythms, transform smartphones into mobile ultrasound devices or help people manage insulin-dependent diabetes.

One new example presented recently at a conference is an experimental, inexpensive iPhone app that helps diagnose heart attacks. It transmits diagnostic heart images faster and more reliably than emailing photo images.

The FDA says industry estimates predict by 2015 there will be 500 million smartphone users worldwide using healthcare applications. And by 2018, half of the more than 3.4 billion smartphone and tablet users will have donwloaded at least one medical or health app.

Supporting innovation while protecting consumers

In issuing its final guidance, the FDA says it recognizes that the “widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.”

The agency asserts that the tailored approach it has adopted in the final guidance “supports innovation while protecting consumer safety,” as Dr. Jeffrey Shuren, FDA’s director for Devices and Radiological Health, explains:

“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation.”


Focus on apps with higher risks

The agency will therefore focus on the minority of apps that pose the higher risk, such as:

  • Apps that allow doctors to diagnose a specific condition by looking at an image from a “picture archiving and communication system (PACS)” on a smartphone or tablet.
  • Apps that turn a mobile device into a regulated medical device. For instance, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms.

The agency says it will review medical apps using the same standards and risk-based assessments that it applies to regular medical devices.

The final guidance follows the draft issued for comment in July 2011, after which the FDA received more than 130 comments, overwhelmingly in support of the agency’s tailored, risk-based approach.

Dr. Shuren says:

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly.”

He adds that the guidance clearly gives app developers the information they need to support their continued development of these important products.

In the last 10 years, the FDA has cleared around 100 mobile medical apps, including about 40 in the last 2 years.

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