… and Cosmetic Act (“FDCA”), CDS software is excluded from the definition … 3 as encompassing only CDS software that does not … added several examples of CDS software functions that provide risk … FDA provides examples of CDS software that would fall outside …

… certain products. CDS Guidance Background CDS software covers a variety of tools …

… devices and clinical decision support (CDS) software supersede the agency’s prior … The January 6 guidance on CDS software, intended to help developers assess … both general wellness products and CDS software, the updated documents reward disciplined …

… FDA when evaluating whether certain CDS software functions are excluded from the … a central theme in the CDS Software guidance. The CDS Guidance builds … statutory criteria that dictate whether CDS software is considered a device, with …

… . FDA Issues Draft Guidance on CDS Software FDA issued draft guidance on … of certain clinical decision support (CDS) software, including AI-enabled products. The … would exempt certain lower-risk CDS software from medical device regulations and …

… New clinical decision support (CDS) software guidance In the CDS software draft guidance, FDA … enforcement discretion. For AI-enabled CDS software products, especially those reliant on …

… products and clinical decision support (CDS) software, superseding the prior versions from … (o)(1)(E) (i.e., CDS software excluded from the statutory “device …

… an updated Clinical Decision Support (CDS) Software guidance, which relaxes several constraints …

… wearables and clinical decision support (“CDS”) software tools. First, FDA released an … the four criteria for a CDS software function that, if met, mean …

… documents on Clinical Decision Support (CDS) software and general wellness products, and … FDA regulation. Clinical Decision Support (CDS) Software FDA updated its guidance on …