Showing posts with label FDA Mobile Medical Apps. Show all posts
Showing posts with label FDA Mobile Medical Apps. Show all posts

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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