FDA: implementation of the UDI rule

The FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. The Agency believes the policy adopted is consistent with public health interests.

Initially, the deadline for implementing the UDI marking on the labeling of class I and unclassified devices was September 24, 2018. That deadline was extended to September 24, 2020 and today, it has been extended for another 2 years, becoming 24 September 2022.

In this same guidance, the FDA also eases the commercialization of class I and unclassified devices manufactured before September 24, 2018 (inventory), which can now be sold without complying with the UDI rule until September 24, 2022.

Changes were also made to the UDI deadlines for direct marking for class II, III and implantable or life support devices that make up the inventory. The deadline for implementing UDI direct marking remains September 24, 2022.

Check out the full guidance on the subjec, click here.

Do you have doubts about the UDI rule? RA Passarini can help you, talk to us!

Contact us: [email protected]

We are ready to help you.

Passarini Regulatory Affairs

Published: 07/01/2020

*Unclassified devices are those for which a classification regulation has not been promulgated.

To share