US EditionUS FDA to limit regulation of health and fitness wearables, commissioner says
The FDA aims to foster innovation by excluding non-medical-grade wearables and AI informational tools from regulation to avoid unnecessary restrictions, officials said.
- On Tuesday, FDA Commissioner Marty Makary announced the U.S. Food and Drug Administration will not regulate wearable devices providing non-medical-grade information and issued new guidance on support tools like Google and ChatGPT.
- The decision aims to give clearer direction, providing guidance for industry and investors as government agencies grapple with rapid artificial intelligence advances, Marty Makary said.
- Makary told `Varney & Co.` that `if their device or software is simply providing information, they can do that without FDA regulation,` and said accuracy should be left to the market for wearable device manufacturers.
- As AI tools improve, the FDA signaled it will not 'crack down' on AI platforms, arguing the old regulatory model is inappropriate as many AI medical devices evolve.
- For the longer term, the FDA wants to balance access and safety as Marty Makary said regulators must promote these products while guarding against major safety concerns and urged letting doctors choose from a competitive marketplace for their patients.
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US FDA to limit regulation of health and fitness wearables, commissioner says
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to clarify its regulatory approach.
FDA commissioner says non-medical-grade wearable data exempt from regulation
FDA Commissioner Marty Makary announced Tuesday that wearable devices providing non-medical-grade information will not be subject to FDA regulation as the agency moves to clarify its approach to digital health and artificial intelligence."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," Dr. Makary told "Varney & Co." "The only stip…
FDA moves to ease oversight of wearable health and wellness devices
Wearable health devices may soon operate under looser regulatory oversight following new guidance from the U.S. Food and Drug Administration (FDA). The agency said Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, aiming to clarify how it approaches oversight in this rapidly growing sector. “We want to let companies know, with very clear guidance, that if their device or software is si…
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