The FDA has issued an extension to the unique device identifier (UDI) compliance deadline for class I devices, after a number of the technological and policy challenges were identified with the class II and III devices. FDA says it is extending the requirements for Class I and unclassified devices to bear a UDI on their labels and packages, as well as the requirement for those devices to submit data to the global unique device identification database (GUDID), from September 2018 to September 2020.
The agency is also delaying the direct mark requirement for Class I and unclassified devices, which requires devices to bear a UDI on the device itself if the device is reusable and must be reprocessed before each use, from September 2020 to September 2022. FDA believe that this extension is necessary in order to fully standardize and optimize UDI data already collected on high-risk devices.
In addition, FDA plans to release new guidance explaining the agency’s enforcement discretion policy for labelling, submission of data to GUDID, standard date formatting and direct mark requirements for the affected devices, although the expected date of release has not yet been published.
To access the full FDA notice, click here.