2024-02-22
We issued a safety communication to warn that smartwatches and smart rings claiming to measure blood glucose levels without piercing the skin are not authorized by the FDA, and relying on them could lead to injury or death if used to make medical decisions https://www.fda.gov/...
MacRumors
The US FDA warns the agency has not “authorized, cleared, or approved any smartwatch or smart ring” that claims to measure blood glucose levels non-invasively
As Apple Reportedly Tests Blood Sugar Tech X: @fdadeviceinfo : We issued a safety communication to warn that smartwatches and smart rings claiming to measure blood glucose levels w...
2023-03-30
The FDA generally intends not to issue “refuse to accept” (RTA) decisions for premarket submissions for cyber devices that are submitted before October 1, 2023, based solely on information required by section 524B of the FD&C Act.
The Record
The FDA says approval for medical devices now requires meeting certain cybersecurity standards issued in the omnibus spending bill signed in December 2022
The Food and Drug Administration affirmed Wednesday that medical device manufacturers must now prove their products meet certain …