This episode examines the FDA’s January sixth final guidance on clinical decision support exclusions under Section five twenty o one E, which now explicitly ties insufficient transparency to automation bias and establishes that opaque models will not satisfy criterion four regardless of labeling. January seventh guidance documents expanded wellness product boundaries to include blood pressure and glucose monitoring in wearables and reversed the prior position that software providing a sole medical recommendation would trigger device status. Clearances covered include AccurKardia’s AccurECG two point zero for automated arrhythmia classification, Welldoc’s five ten K submission for continuous glucose monitor informed prediction in non insulin dependent type two diabetes, Etiometry’s tenth clearance for cybersecurity and waveform integration, and Siemens Healthineers’ seventy centimeter Magnetom Flow MR platform with helium free cooling technology. The episode concludes with the formal start of user fee reauthorization negotiations ahead of the September twenty twenty seven deadline, which provides a legislative vehicle for potential policy changes across FDA review processes and post market monitoring obligations.
