Topic archive
MedTech Current publications and recall entries tagged Digital Health & Wearables.
The 9 October 2026 rule codifies a classification applicable since November 2023. Its seven groups of special controls connect sensor quality, clinical performance, alarms, usability and labelling; the device type remains subject to 510(k).
Australia's TGA announced amendments clarifying the Clinical Decision Support System exemption effective 1 November 2026, defining boundaries between excluded software, exempt CDSS, and regulated SaMD.
ANVISA has clarified that smart rings currently marketed as wellness or sports products should not be used to diagnose disease, and that products presently available are not regularized for non-invasive glucose or oximetry measurement. The update reinforces that intended medical purpose and promotional claims can determine whether a wearable falls within the medical-device regulatory framework.