The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
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FDA announces regulatory exemptions for ‘non-medical grade’ devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...
The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...
In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
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