U.S. FDA Issues Updated Guidance on Medical Device UDI Compliance

The U.S. Food and Drug Administration (FDA) has issued an updated Guidance on its unique device identification (UDI) labeling requirements for medical devices.

Under the terms of the Guidance, which was issued in early November, device manufacturers of most Class 1 and unclassified medical devices will be allowed to continue to market UDI devices manufactured prior to the implementation date of the FDA’s new UDI labeling and data submission requirements, even if the labeling of those devices does not conform with the FDA’s labeling requirements.

The change is intended to provide device manufacturers with more flexibility regarding the disposition of UDI medical devices in inventory that do not bear the required labeling.

FDA rules regarding labeling and data submission requirements applicable to UDI systems in most Class 1 and unclassified medical devices are intended to facilitate submission and posting of listings to the Global Unique Device Identification Database (GUDID) for UDI systems. Although these requirements were due to be phased in starting this past September, the FDA now says that it does not intend to enforce the requirements prior to September 2022.

Read the complete text of the FDA’s updated Guidance on its UDI labeling policy for medical devices.

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