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FDA to Limit Oversight to Medical Device Mobile Apps

iPhone (William Hook/Flickr)The U.S. Food and Drug Administration will focus its regulation of mobile health apps on those that act as traditional medical devices, according to final guidance released yesterday. The guidance, to be published tomorrow in the Federal Register for public comment, says FDA will not enforce regulations on the majority of health-related smartphone and tablet apps that under current law do not meet the definition of medical device.

The guidance document recognizes the growing role played by smartphones and tablets in aiding health and wellness, including apps that help individuals manage their health and other apps designed to improve delivery of professional health care services. But the guidance also recognizes the limitations of the technology, where for example, a mobile device’s smaller screen and lower contrast can distort the display of X-ray images.

FDA says it will use its “enforcement discretion” to concentrate its regulatory oversight on the fraction of medical apps that can pose a risk to consumers if they do not work as intended, using the legal definition of medical device to determine that threshold. The Federal Food, Drug, and Cosmetic Act says a device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory” that is

– Recognized or acts like a drug or supplement, but does not work through chemical action

– Designed to diagnose, mitigate, treat, or prevent a disease

– Intended to affect bodily functions or structure

The definition applies to devices designed for animals as well as humans. In addition, FDA’s oversight will apply to apps used as accessories to existing medical devices as well as apps that transform the mobile platform into a regulated medical device.

The app’s intended use for medical purposes — as published in its packaging, advertising, or published statements —  will guide much of the FDA’s scrutiny, according to the guidance. The document cites as an example a mobile app that operates an LED light. If that LED is intended to be used for general illumination, it would not be considered a medical device. If, however, the LED is marketed as illumination to examine a person’s eyes, it would be classified as a light source for an ophthalmoscope, and regulated accordingly.

The document says as well that FDA will apply its oversight to developers of mobile apps, not their distributors, such as Google Play or Apple’s iTunes App Store.

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Photo: William Hook/Flickr

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