FDA Delays UDI Deadline for Class I Devices to September 2022

FDA Delays UDI Deadline for Class I Devices to September 2022

The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices.  Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...
The Latest UDI News: Convenience Kits Q&A from the FDA

The Latest UDI News: Convenience Kits Q&A from the FDA

Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labelling of...