FDA regulations

NEWS & BLOGS

Blog: Blog2

Medical Devices Have IDs Too — The FDA UDI Guide for U.S. Market Entry

A patient arrives in the ER. The medical team needs to quickly identify an implant placed years ago. Or a recall notice lands at a hospital — and no one can immediately tell whether the devices on the shelf are affected. This isn't hypothetical. It happens. The FDA's answer to this problem looks, on the surface, like just another barcode requirement. But it's something much bigger: the UDI (Unique Device Identification) system. And for any company selling — or planning to sel

FDA Regulations