Smartphones Back Away from Regulatory Claims. What's Your Strategy?

Are smartphones medical devices? Well of course they aren’t. Except when they are. Then they really are.

Apple iphone connected to an imaginary BP cuff on screen.First, anything is a medical device if it meets FDA’s definition of a device. “If it quacks like a duck—is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (or other health related conditions like injury), it is a duck. Calling it a chicken or even a turkey does not change a regulatory agency’s perception of the quacking product’s “‘duckness,’” says Tim Gee at Medicalconnectivity.com.

It is also a medical device if it is considered a medical device data system (MDDS). This new category from FDA is reserved for those products involved in acquiring data from one or more devices, storing the data, transforming them, displaying, and otherwise making them available to other applications.

Simply put, however, companies that manufacture products that make claims to be medical devices or perform clinical operations will be considered medical devices. For example, say a software vendor creates an app to view DICOM images on the iPhone and iPad but expressly states that it can’t be used to render an actual diagnosis. So then, what is the app for? FDA says it is a medical device.

Smartphone companies have been backing off their claims to be considered medical devices, after some trouble. “Apple came perilously close to claiming the iPhone was a medical device during their iOS 3.0 intro event. Since then, Apple’s toned down their aggressive marketing of the iPhone (and iPad) as medical devices, though they still show examples of medical device applications in commercials, at events and on their web site,” says Gee.

Gee’s basic advice for manufacturers is to track regulatory actions. General purpose products and services (smartphones, cell carrier networks, WiFi equipment) should develop a regulatory strategy (either to help you move into the healthcare space or to move away from it).

—Heather Thompson