FDA Exempts Certain Decision Support Tools From Enforcement

FDA on Thursday (Dec. 7) took steps to fulfill the digital health provisions in the 21st Century Cures Act by issuing a suite of guidances that reveal which clinical decision support (CDS) tools won't be considered devices. FDA Commissioner Scott Gottlieb told lawmakers during a Senate hearing Thursday that including patient decision support software among the products exempted is FDA's way of adhering to Cures, while also going beyond Congress' mandates. Gottlieb said he hopes the guidances and FDA's approach...