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Accelerator Offers Mobile Medical App Regulatory Guide

iPhone (William Hook/Flickr)Rock Health, a health care start-up accelerator in San Francisco, prepared an online guide to help developers of medical apps for mobile devices better understand the Food and Drug Administration’s review processes. The guide is written as an online slide presentation, viewable below and available through SlideShare.

The need for the guide is growing, says Rock Health. The group estimates there are some 60,000 medical-related mobile apps for iPhone and Android devices offered through their respective app stores. In addition, many app developers come from outside the medical device field and will not be familiar with even basic FDA requirements.

The Rock Health guide is based on FDA’s July 2011 draft guidance on mobile medical applications. As FDA gets closer to issuing its final guidance, Congressional interest in the process has also increased. The House Energy and Commerce Committee held three days of hearings last week on health information technologies. FDA is expected to issue its final guidance by 1 October 2013.

In the meantime, Rock Health assembled pointers and guidance from FDA’s current regulatory practices, including device classifications and premarket requirements for regulated products in the digital health field. Rock Health also gathered insights from entrepreneurs who have already gone through the process.

The guide helps mobile device app developers decide if their products are covered by FDA regulations and the pathways to take for FDA clearance. In addition, the guide indicates the materials app developers need to assemble for their regulatory submissions.

Rock Health’s guide also offers pointers and best practices from the FDA experiences of entrepreneurs and developers. FDA has already reviewed about 100 mobile medical apps, which they classifiy mainly as low or medium risk devices, Class I and II respectively. Rock Health says the average FDA review time for mobile medical apps so far is 67 days, compared to premarket notification reviews for other medical devices of 143 days, based on data from the government’s 2011 fiscal year.

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Photo: William Hook/Flickr

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