FDA relaxes oversight for wellness devices

The US Food and Drug Administration (FDA) announced on 6 January that it is loosening restrictions on wearables, including devices that measure blood glucose, blood pressure and other AI-enabled tools. The changes aim to spur innovation for digital wellness products and clarify previous guidance from the agency.

FDA commissioner Marty Makary announced the changes at the Consumer Electronics Show in Las Vegas. Previous guidance “didn’t always make a lot of sense from the outside,” he remarked in his speech. It had “unintended consequences” that “forced” developers to “build dumber software,” he said.

This is a preview of subscription content, access via your institution