FDA Clears (Not) The First IPhone App

FDA has been approving mobile device apps for at least 5 years, the more interesting questions are about how to make sure these devices are safe, effective and - for the developer - can be easily validated

There's been a lot of excitable and breathless reporting over the last week or two about FDA's first 510(k) clearance of an iPhone app (the Mobile MIM).  Even august journals such as Scientific American got in on the act.  But not so fast.  FDA has been quitely approving iphone and other portable/remote software apps for some time now. More about that in a moment.    The novelty in this latest approval was that it was the first app for the specific application of viewing diagnostic radiology images from CT, PET and MRI.  Essentially this particular app allows the images to be sent to the physicians iPhone for instant viewing remote from the radiology clinic.  

Records System or medical device?

FDA overseas medical devices - which are essentially any thing (including software) with a direct therapeutic or diagnostic functionality.  Software that simply acquires, stores or moves to other locations medical information - including images, is generally considered a medical records system - which is in most cases exempt from FDA oversight.  Systems to ship such medical records from the clinic to remote servers and personal computers including remote laptops have been around for quite some time now, and the extension of these applications to smaller and smaller devices, including PDAs and smartphones is an inevitable progression.

A quick search of the FDAs online database of 510(k) approvals throws up several devices cleared by FDA over the last year including the Airstrip RPM (cleared July 2010).  AirStrip is an iPhone App which delivers a whole range of physiological data, gathered by bedside diagnostic devices and relayed through a clinical data management system to the physicians iPhone wherever she is.  The data displayed range from things like ECG and blood pressure waveforms, blood gases, and specific invasive blood pressure readings. These data can be presented on the iPhone along with other patient record information such as medications, allergies and laboratory data.  The Airstrip approval was based on a comparison under the 510(k) substantial equivalence rules to two other applications - including the  GE pocket viewer (cleared January 2006) as an application running on Windows Mobile PDAs and generic cellphones to view clinical data) and the Cerner iBus (cleared November 2009)

Validation of Medical Software

Crucially the MIM Mobile software includes a contrast test to ensure that the image and local lighting conditions are good enough to allow the physicain to make a diagnostic interpretation of the image, right there from the iPhone screen.  That diagnostic functionality makes it a medical device rather than simply a medical records system.  Reading the FDA press release makes it clear that FDA paid particular attention to review of the validation of the the ability of the app to prove images of sufficient quality for diagnostic purposes.  and this is the central issue.  

However, while the applications have migrated to increasingly small and mobile hardware, the regulatory framework has  remained happily agnostic to the platform.  Software with a therapeutic or diagnostic function is considered a medical device in all jurisdictions.  The revision of the European medical Devices Directive in 2007 made it very explicit that such software is a Class IIa or above medical device in Europe, and the same applies in other GHTF jurisdictions including e.g. Canada and Australia.  The current consensus standard which underpins approval in Europe or by FDA is IEC 62304:2006: Medical device software -Software life cycle processes.  This standard sets out requirements for development and maintenance of valisated software for medical use.

But isn't it different for iPhones - after all, Apple is famous for its jealous protection of its software and hardware IP - how do you validate the iPhone and the iPhone operating system if you don't have the source code?  This too is not a new problem and medical device software developers have been validating aplications running on proprietary platforms - typically Windows for years.   Typical solutions involve black box validations in which the system is tested for robustness of output based on extreme data inputs.  interestingly in the case of Mobile MIM, the validation has relied on inclusion of a straightforward control image to verify that the lighting conditions allow for the clinician to view and discern adewquate levels of image contrast.  

So is it a brave new world - not necessarily so.  In fact FDA Guidance on validation of "off the shelf" software has been around since last century :). 

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