The ease of application development afforded by the extensive community surrounding portable devices like the Apple iPhone/iPad has led to a surge in medical device-like apps being released for smart phones and tablets.  An article published by Siren Interactive quoted a MobiHealthNews study that found more than 7,000 medical apps available for the iPhone in 2010, covering a wide range of different healthcare issues and medical services for their users.

At MDCI we are frequently asked by both clients and potential clients as to what exactly constitutes a medical device when examining the world of software apps such as those available through iTunes.  This is a complex question, and it might seem as though FDA regulations have lagged behind in recent years in terms of keeping up with the fast-paced world of medical app development.

In December of 2010, the mHealth Regulatory Coalition published a white paper which was intended to clear up many of the misconceptions surrounding the classification of apps as medical devices.  The stated goal of the mHealth Regulatory Coalition is to help the FDA develop guidance documents which are capable of outlining specifically what app developers must be familiar with from a regulatory perspective when bringing their products to market.  The term “mHealth” itself refers to mobile communications in the medical sphere, a segment of the industry that has so far outpaced the FDA’s ability to develop a consistent regulatory approach.

The white paper is titled “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth.”  The document poses a series of pointed questions that the mHealth Regulatory Coalition feels need to be answered from a regulatory standpoint by the FDA, including whether health apps that run on mobile phones transform those phones into medical devices, how to handle medical data which is stored either on a mobile device or in the cloud and how to differentiate between apps which promote wellness versus apps which clearly focus on the treatment or management of a disease.

There is no question that changes are coming to the health app industry as the FDA begins to develop a comprehensive strategy for dealing with medical app regulation.  With growth in the medical app sector showing no signs of slowing down, the FDA will undoubtedly find itself inundated with approval applications once the first wave of regulatory decisions are made.  Partnering with an experienced player such as MDCI can give health care app developers the advantage they will need in order to cut through the noise and bring their product to market as quickly as possible.

Benjamin Hunting
MCDI Blogging Team

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republished and adapted with permission from the MDCI Blog