What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? The deadline for 2020 is fast approaching.
Class I devices, and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI, must bear UDI as a permanent marking on the device itself if the device is one that is intended to be used more than once and intended to be reprocessed before each use. §801.45. The compliance date is September 24, 2020.
In this session of Reed Tech Insights, review some critical reminders for Class I medical devices as the deadline approaches.
As you are navigating the guidance and completing UDI requirements, Reed Tech is available to help with SingleSource™ for Medical Devices. Expert Reed Tech staff work with your regulatory team to smoothly navigate each stage of UDI data submission – especially if you have limited staff resources to devote to UDI data compliance.
Contact us to learn more: MedDevice@ReedTech.com