Login

NON-SUBSCRIBER OPTIONS
FREE TRIAL   |   NEWSSTAND

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

By Beth Wang
September 30, 2019 at 3:43 PM
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horrible” and “legally wrong” language in the revised version of FDA’s clinical decision support software (CDS) draft guidance, which clarifies which CDS tools under the provisions of the 21st Century Cures Act are no longer classified as medical devices and thus are not regulated by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...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on the coming Democrat-controlled House of Representatives, drug pricing reforms, Medicaid policy, FDA news and much more.