Majority of medical apps won't be FDA regulated

Stefan Mileschin · 25th September 2013, 08:56

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.

http://www.engadget.com/2013/09/24/f...&ncid=rss_semi

25th September 2013, 08:56	#1
Stefan Mileschin [M] Reviewer Join Date: May 2010 Location: Romania Posts: 148,462	Majority of medical apps won't be FDA regulated 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. http://www.engadget.com/2013/09/24/f...&ncid=rss_semi

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