CDS Coalition Provides Input on the Cures Act Section 3060 Report That FDA Is Required to Produce This Year
In response to FDA’s May 29, 2018 request for input, on June 21, 2018, the CDS Coalition provided feedback on the benefits and risks to health associated with the medical software functions excluded from the FDCA “device” definition by the 21st Century Cures Act. Specifically, the Coalition offered information on: (1) the benefits of CDS software; and (2) industry’s efforts to develop and implement guidelines that identify appropriate disclosures designed to promote “safety, education and competency” related to CDS software unregulated by FDA.