The FDA’s Center for Devices and Radiological Health released a draft guidance proposing regulatory expectations for cuffless blood‑pressure monitoring devices. The agency aims to clarify evidence, performance metrics and marketing claims for over‑the‑counter and prescription cuffless technologies, citing growth in unauthorized devices on the market. Manufacturers of wearable blood‑pressure technology will need to align to the draft guidance’s validation and labeling requirements. The document signals the FDA’s intent to tighten oversight of cuffless BP tools as consumer adoption rises and clinical use expands.