Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance
Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements...
FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...
Let us help you on the path to UDI Compliance for FDA with Innovit’s GUDID Reference Center
Are you preparing for the FDA’s enforcement of UDI labeling and GUDID (Global Unique Device Identification Database) data submission requirements for Class I and unclassified devices, coming up in September 2022? Your company should start to aggregate, validate and...