In the final guidance, the FDA clarifies its oversight of CDS software and shares its thinking on which software functions are now excluded from the definition of a medical device due to the enactment of the 21st Century Cures Act in 2016. It also provides examples of how the FDA applies the criteria used to make that determination.
The FDA had initially published its draft guidance in September 2019. The new guidance can be found on the FDA's website.
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