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23andMe and FDA are playing nice under Congress's watchful eye

23andMe and FDA are playing nice under Congress's watchful eye | UX-UI-Wearable-Tech for Enhanced Human | Scoop.it

Warming relations between the company and the regulator may be driven by Congressional threats to limit the FDA's oversight power.

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FDA issues final guidance on mobile medical apps

FDA issues final guidance on mobile medical apps | UX-UI-Wearable-Tech for Enhanced Human | Scoop.it

Here is the result of the FDA regulation evolution on mobile medical Apps. 

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. 

 

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices. 

The agency does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the ‘iTunes App store” or the “Google Play store.” 

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