FDA guidance eases wearables oversight. But experts have questions about what’s next.

MedTech Dive January 27, 2026
Elise Reuter

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The agency suddenly issued a pair of guidances earlier this month, intended to clarify its approach to wellness devices and medical software.

The updates reflect changes to the agency’s thinking about what counts as a wellness device, but also raise new questions and pose challenges to consumers, experts said.

FDA Commissioner Marty Makary announced the pair of guidances — issued without any prior notice or public comment period — at the Consumer Electronics...

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