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FDA Will Regulate Some Apps As Medical Devices

chicksdaddy (814965) writes | about 7 months ago

0

chicksdaddy (814965) writes "In an important move, the U.S. Federal Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on devices like the iPhone and Android mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices.

The statement is the final word from the FDA on the approach it will take when enforcing federal regulations regarding the safety of medical devices to the large and fast-growing category of medical applications. The agency said on Monday that, while it doesn’t see the need to vet “the majority of mobile apps,” because they pose “minimal risk to consumers,” it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device.

In those cases, the FDA said that mobile applications will be assessed “using the same regulatory standards and risk-based approach that the agency applies to other medical devices,” The Security Ledger reports.

The line between a mere "app" and a "medical device" is fuzzy. The FDA said it will look to the “intended use of a mobile app” when determining whether it meets the definition of a medical “device.” The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, “when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure of any function of the body of man, the mobile app is a device.”"

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