The FDA and Today’s Smartphones
Just as state licensing laws consider diagnosis and treatment to be the province of the MD, the FDA considers any product whose intended uses include the diagnosis and treatment of disease to be a medical device—including a mobile phone—bringing it under the purview of the FDA. Medical devices, for example, can include anything from X-ray equipment to tongue depressors.
Recently, the FDA has tackled the question of whether mobile apps can be considered medical devices, which would subject them to FDA regulation. For manufacturers and software publishers, the consequences of such a decision could be staggering. Medical devices must meet host of regulatory requirements, including registration of the manufacturer and the device and a prohibition on introducing the product to market unless it receives premarket approval from the FDA or is “substantially equivalent” to a “predicate” (or similar) device already on the market.
Proving substantial equivalence requires a submission to the FDA of a document known as a 510(k) (based on the applicable statutory section of the federal Food, Drug & Cosmetic Act), which can be burdensome and expensive. Among other things, the FDA can ask the manufacturer for proof of performance effectiveness, which can require costly clinical trials. Medical devices also have special labeling requirements, and manufacturers must establish quality system regulation, report adverse events, and abide by other regulatory requirements.
What is Considered a Mobile Medical App
In its Mobile Medical App Guidance, the FDA states that not all health-related apps are to be considered medical devices. In general, only apps that are used as an accessory to a regulated medical device or that transform a mobile platform into a regulated medical device are considered mobile medical apps and are, therefore, subject to FDA regulation.
To give an example, the light-emitting diode (LED) with a mobile app on your smartphone that is intended to illuminate objects generally would not be considered a medical device. But if the manufacturer promoted the LED as a light source for examining patients, then the app would meet the definition of a mobile medical app and would be subject to FDA requirements.
The FDA points out that many apps on the market today simply log, record or track general health and wellness data and would not be considered mobile medical apps. For example, a calorie counter app that allows you to track your food intake and calculate calories does not diagnose or treat disease and does not, therefore, transform your phone into a medical device. But if that same app contained a clinical algorithm to determine how many calories of protein you need to keep your hypoglycemia under control, it could potentially be considered a mobile medical device.
What FDA Mobile Medical App Guidance Means for Consumers
Although the FDA’s guidance of medical apps primarily affects app designers, forward-thinking consumers should understand that the mobile medical app guidance by the FDA marks a significant increase in the FDA’s ability to affect the ordinary life of a smartphone user.
Phone technology continues to move in the “tricorder” direction, with no end in sight. At some point, there will be no such thing as a “dumbphone” and, if current rates of adoption are any indication, our phones will be indispensable. As technology accelerates, people will rely more and more on their devices for feedback and guidance regarding their health. Where today’s phone tells you where to turn left, tomorrow’s phone may advise you to put down that donut. Or, if the person next to you suddenly collapses, your smartphone may be able to analyze and transmit their vital signs—pulse, respiration, blood pressure, etc.—directly to a 911 operator. The line between medicine and health is blurring again, and you and your device are a part of the transformation.
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