regulatory oversight

drag2share: Majority of medical apps won’t be FDA regulated

source: http://www.engadget.com/2013/09/24/fda-medical-apps/?utm_medium=feed&utm_source=Feed_Classic&utm_campaign=Engadget&ncid=rss_semi

FDA adopts riskbased approach to medical app regulation

App catalogs are flush with titles that allow users to play doctor, but according to the FDA, most of them are harmless and don’t warrant regulatory oversight. Instead, the agency has announced that it’ll take a more reactive, risk-based approach and will only require approval for mobile apps that “present a greater risk to patients if they do not work as intended.” Specifically, the FDA will scrutinize apps that perform the functions of regulated medical devices — such as an ECG monitor — along with those that are used as accessories to regulated medical equipment. As a telling statistic, only 100 mobile apps have received FDA clearance within the past decade, so imagine what would happen to the agency’s workload if it tried to exercise control over the Apple App Store and Google Play Store combined.


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Tuesday, September 24th, 2013 news No Comments

Dr. Augustine Fou is Digital Consigliere to marketing executives, advising them on digital strategy and Unified Marketing(tm). Dr Fou has over 17 years of in-the-trenches, hands-on experience, which enables him to provide objective, in-depth assessments of their current marketing programs and recommendations for improving business impact and ROI using digital insights.

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