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FDA Will No Longer Regulate Certain Medical Software

The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.

Entrance to FDA headquarters in Maryland

The US Food and Drug Administration will no longer consider eight medical software functions as medical devices, which removes them from regulatory oversight. The rule makes it easier for manufacturers of such software to develop and update their product as long as it fits within the agency’s narrow definition for exclusion.

The FDA on 16 April published a final rule that goes into effect on 19 April that excludes the eight medical device classification regulations that were amended to exclude software functions that are not medical devices.. While very sudden, the rule has been a long time coming and is required under the 21st Century Cures Act that was enacted in late 2016

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