FDA's Approach to Mobile Devices Becoming Clearer

The US Food and Drug Administration (FDA) has cleared two mobile applications for use as medical devices, potentially answering broader industry questions about how the regulator would view such products as they become more frequently used for health care-related purposes.

First, the regulator granted 510(k) clearance for MobiUS, a smartphone-based ultrasound imaging application developed by Redmond, Wash.-based Mobisante, Inc. for use in obstetric, gastrointestinal, cardiac and other clinical applications. Second, the FDA cleared a mobile diagnostic radiology application, Mobile MIM, from Cleveland-based developer MIM Software Inc. The product facilitates viewing of medical images for diagnostic purposes via Apple’s iPhone and iPad devices.

In a press release issued by the FDA following Mobile MIM’s 510(k) clearance, the regulator emphasized factors of speed and efficiency provided by the application—factors that will no doubt affect future FDA clearance decisions for other mobile devices filing 510(k)s. Other mobile medical device application developers intent upon gaining FDA clearance should also pay heed to how the regulator evaluated the Mobile MIM product, as that evaluation will likely serve as a blueprint for future 510(k) considerations.

The FDA reviewed Mobile MIM performance test results on multiple portable devices in order to measure luminance, resolution and noise according to international standards. Results of demonstration studies with radiologists were also reviewed to confirm that the device provided adequate image interpretation according to its recommended lighting conditions. The device’s labeling and safety features were cited as robust enough to minimize poor image displays—a risk all mobile device developers must address in order to pass muster, presumably.

That the FDA announced two 510(k) clearances for mobile medical device applications so closely together may indicate a sense of urgency in response to industry requests for more clarity regarding how such devices will be regulated. Regardless of the FDA’s intentions, however, mobile application developers now have a better idea of what their products will have to incorporate in order to optimize their chances of achieving clearance.

Update: Mobile MIM and MobiUS are not the first mobile medical device applications cleared by the FDA. Airstrip Technologies's Airstrip RPM was cleared in mid 2010.

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