The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE!

Under FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 years. So be careful, there are just over 3 months left!

The UDI rule applies to medical devices that are being marketed in the U.S. Remembering, the UDI rule consists of the UDI implementation in two formats on the device packaging, adequacy of the date formats and feeding of the UDI database (GUDID). For Class II devices, which in the vast majority are eligible for 510 (k), the UDI rule has been mandatory since September 24, 2016.

Failure to comply with the UDI rule is a violation of the Federal Food, Drug and Cosmetic Act and is liable to penalties that include, but are not limited to, misbranding, seizure, recall, and applicable civil and criminal penalties.

Note: This implementation deadline does not apply to implantable, life support or life sustainable class I devices.

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Passarini Regulatory Affairs

Published: 06/05/2020

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