By Clinical Research News Staff

November 12, 2026 | As consumer health wearables move closer to medical territory, product makers need clinical data that supports their claims, whether or not they plan to seek FDA clearance, according to regulatory and clinical research experts at DCN Dx.

The issue gained attention after the FDA’s warning letter to Whoop last year. The agency followed with updated general wellness guidance in January 2026. Dan Simpson, DCN Dx’s director of regulatory affairs, says the guidance changed only modestly from the 2019 version. A product can still become a regulated medical device once it mentions a specific disease state.

Emily Friedland, vice president of DCN Dx’s clinical research services business, says companies should “understand what claims you’re trying to make about your device and whether that meets the wellness standards.” In her view, any device should be backed by data, whether the data goes to the FDA or supports advertising and labeling. Credibility improves, she adds, when the evidence matches the intended claim, population and use setting.

Validation matters even more for AI-enabled products. Simpson says sponsors must show the FDA how their algorithms were trained and how they reach their conclusions. The FDA’s predetermined change control plan (PCCP) framework now lets manufacturers specify future modifications and validation methods in advance. Simpson points to Apple as a model: the company partnered with major medical institutions on large digital health studies before adding cleared functions to its watch.

Read Deborah Borfitz's full story at Integrative Practitioner.