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FDA updates app lists for Mobile Medical Apps


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In September of 2013 the FDA released its final guidance on Mobile Medical Apps and listed the apps that fall under it’s jurisdiction, and a number of these application types that would be given “enforcement discretion” and not require 510(k) certification. All three types of app lists were updated:

Apps that are regulated

Apps given a pass under “enforcement discretion”

Apps that are not regulated

Source: FDA.gov

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