FDA Developing Framework For Medical App Regulation

Posted on June 13, 2013

The burgeoning nature of the medical app industry is something that no one could have predicted ten years ago.  As more and more hospitals and doctors across the country begin to adopt apps for a variety of purposes, the Food and Drug Administration is trying to come to terms with these new innovations and develop a framework that can be used to ensure proper regulation.

A new report takes a look at this idea in greater depth, using a recent warning letter to the India-based Biosense Technologies as a jumping-off point.  The FDA explained to the company that their app, which analyzes the results of urine tests, constitutes a medical device because they take the reading of a test strip out of human hands.  As a medical device, it would need FDA approval.

The FDA first made its intent to regulate medical apps known around two years ago, when they released a proposed series of rules.  At this time, the FDA has not finalized those rules but hopes to get them out at some point in 2013.

Regulating medical apps can become a complicated process.  Although the FDA largely seems to want to regulate any app that makes its own diagnosis, some wonder whether regulation would then apply to apps that compile patient information and make calculations on the fly for healthcare professionals.

Developers worry that passing an app by the FDA will be a lengthy, costly, and/or difficult process.

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