The U.S. Food and Drug Administration (FDA) is issuing a critical warning regarding the use of smartwatches or smart rings to measure blood glucose levels without piercing the skin. Despite claiming to provide blood glucose readings, these devices have no FDA authorization, clearance, or approval for this purpose.
As MDRu is a unit dedicated to the regulatory support of medical devices for various markets, including FDA approval, we emphasize the paramount importance of using devices that are properly certified and approved by competent authorities. Like the FDA, we strongly advise against the use of smartwatches or smart rings to measure blood glucose without piercing the skin. The use of these unapproved devices can result in significant errors in diabetes management, potentially leading to dangerously low glucose levels and serious health complications.
If you have a product that requires FDA approval or are looking for guidance on regulatory issues, please do not hesitate to contact us or visit our website: https://lnkd.in/dPbMTdSs
Let’s ensure the safety and efficacy of medical devices together.