Healthcare IT News November 8, 2021
Mike Miliard

The new document, published this past week, takes stock of a fast-changing technology environment – and would replace the agency’s previous medical device guidance, first issued more than 16 years ago.

This past week, the U.S. Food and Drug Administration published draft guidance for its Content of Premarket Submissions for Device Software Functions.

WHY IT MATTERS
The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions.

The FDA’s draft recommendations pertain to device software functions – software in a medical device (SiMD) and software as a medical device (SaMD), most notably – and describe data that would be generated...

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