FDA Extends the Compliance Dates for Implementing UDI for Class I Devices
The FDA has recently announced a date change for when low risk medical (dental) devices must be UDI compliant. The new implementation date for Class I and unclassified devices is now September 24, 2020. The previous compliance date for Class I devices was September 24, 2018.
UDI implementation for Class III and Class II medical devices has already gone into effect. UDI is mandatory to sell medical devices in the US. Several steps are involved to implement Class I devices for proper UDI labeling and uploading on the GUDID web site. For more information on the new Class I device compliance dates or what steps are required to become UDI compliant, please visit the FDA web site.