Device Expert Says FDA’s CDS Guide Revision Could Raise Legal Issues

A medical software industry lawyer called out what he sees as “absolutely horrible” and “legally wrong” language in the revised version of FDA’s clinical decision support software (CDS) draft guidance, which clarifies which CDS tools under the provisions of the 21st Century Cures Act are no longer classified as medical devices and thus are not regulated by FDA. In one new section, FDA makes the distinction between software that helps in clinical decision-making and software that is used to drive...