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# Makary Touts Less Oversight on Wearables
- URL: https://www.fdaweb.com/makary-touts-less-oversight-on-wearables/
- Published: 2026-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:30:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160448

In a significant policy shift aimed at modernizing federal oversight of digital health technologies, FDA commissioner **Marty Makary** is promoting limited regulatory scrutiny of many wearable devices and software tools, especially those that provide general wellness information rather than medical diagnoses or treatment guidance. The move, outlined by Makary’s comments and new agency guidance ([see earlier story](https://www.fdaweb.com/two-digital-health-guidances-published/)), is intended to reduce barriers to innovation while maintaining safety protections for consumers.

At the core of the FDA’s revised approach is a clearer distinction between non-medical wellness products — such as fitness trackers, sleep monitors and activity apps — and medical-grade devices that claim to diagnose or treat health conditions. Under the new policy, devices and digital tools that simply provide information about general health metrics or encourage healthy behaviors will generally be exempt from stringent FDA regulation, provided they do not market themselves as diagnostic or clinical tools

“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” commissioner Makary said in an interview with *Fox News*, emphasizing that regulatory oversight will remain where devices make medical claims or report clinical-grade measurements. Examples of regulated features include blood pressure measurements or other outputs that could influence medical decision-making.

Makary framed the policy adjustment as part of a broader effort to adapt FDA’s role to the rapid expansion of artificial intelligence and digital health tools, which have outpaced traditional medical device regulatory frameworks. “We have to promote these products and at the same time just guard against major safety concerns,” Makary remarked. He noted that for technologies such as AI-powered symptom checkers or health information assistants, physician consultations should be the context in which such outputs are interpreted.

FDA’s guidance documents also reflect industry and investor expectations for more regulatory clarity. The regulatory move comes amid broader debate on the role of AI and data-driven tools in healthcare, and follows past agency actions that sought to clarify the line between wellness and medical devices. For instance, the agency last year issued a warning to fitness tech company WHOOP for offering blood-pressure insights that it viewed as crossing into medical device territory without proper authorization ([see story](https://www.fdaweb.com/fda-warns-firm-marketing-blood-pressure-estimator/)).