Monday, September 23, 2013

FDA focusing its oversight on mobile medical apps

Article Title: FDA issues final guidance on mobile medical apps
Snippet of Article: "...The FDA is focusing its oversight on mobile medical apps that: * are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or * transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack...."


Source: /www.fda.gov

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