GlobalData on MSN

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 ...
ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Fierce Healthcare

FDA paves way for more consumer wearables, AI-enabled devices to hit the market

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
Reason

Chatbots Are Not Medical Devices

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 ...
ProPublica

The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices, Watchdog Report Finds

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration rarely uses its authority to ...