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US FDA Requests Input For New Report On Non-Device Software Functions

 
• By Brian Bossetta

The US agency is seeking input in developing a report on the health benefits and risks of software functions that do not fall under the medical device definition.  

FDA Computer Screen
• Source: Shutterstock

The US Food and Drug Administration has long regulated software that meets the definition of a medical device. And as the FDA notes, with the continued advancement of technology in health care, software has become integral to many devices and digital platforms that serve medical – and non-medical – purposes.

“Software as a medical device (SaMD)” is defined as software intended to be used for one or more medical purposes...

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