The FDA’s Center for Devices and Radiological Health issued draft guidance focused on cuffless blood‑pressure monitoring devices, signaling tighter oversight as over‑the‑counter, cuffless products proliferate. The draft guidance outlines performance, validation and labeling expectations for manufacturers developing cuffless BP systems. Manufacturers and health systems will need to align development and clinical‑validation plans with these expectations to avoid market access setbacks. The guidance is part of a broader FDA push to clarify regulatory pathways for consumer and clinical wearables that claim medical measurements, and it will influence device design, trial strategy and reimbursement discussions.