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What FDA Tracking Requirements Mean to Medical Apps

Like contaminated food, malfunctioning medical equipment poses a major threat to human health. Due to the risk that improperly-working medical instruments potentially pose to society, the FDA’s Modernization Act (FDAMA) regulates distribution of these devices. To obtain FDA approval, tracking codes are required for some types of medical products, which allow for easier notification and product recall if necessary.

Today’s medical “devices” aren’t all handheld equipment, though. Medical mobile apps have become a go-to source for health information for many consumers. Most of these health apps are considered low-risk, and require no FDA clearance. The FDA has pinpointed two distinct app types that they believe pose enough risk to human wellness to regulate: apps designed to “transform a mobile platform into a regulated medical device” and apps “intended to be used as an accessory to a regulated medical device”.

Apps that “transform a mobile device,” include that use a sensor connected to a mobile platform to measure any type of essential body signal or component (heart, neurological, blood type). Apps considered accessories are those that connect to existing devices (infusion pumps, X-ray machines, cochlear implants) and have the ability to change settings on those devices.

With the popularity of mobile apps, health apps are hitting the market in large numbers, and the FDA process for handling them has been to amend and adjust approval requirements as new technology arises.

Final guidance for medical apps was released by the FDA in September 2013, and the basic outcome was that most health apps are in the clear. Health apps that do not have a direct effect on human health, such as calorie counters and weight calculators, are unlikely to ever require any type of regulating. As for those mobile platforms that have the power to alter existing equipment, or to be used in the place of regulated equipment, though, they are under the U.S. Food and Drug Administration’s watchful eyes.