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Recently, the Food and Drug Administration released final guidance concerning the labeling of medical devices that are distributed for use in the United States. This guidance requires a Unique Device Identification (UDI) label to be affixed to each of these devices.

The UDI label contains several pieces of information that will lead to a higher quality of information, a reduction in errors and more accurate reporting in the medical field. Arbour Group's experienced professionals are extensively trained to evaluate a client's readiness as well as assist with UDI Compliance.

Unique Device Identification (UDI) number consists of the following components:

The Device Identifier (DI): a fixed portion of the UDI that serves as a device identifier and also gives the labeler and the specific model and version of the device.

The Production Identifier (PI): a variable portion of the UDI that identifies the following information when included on a device's label:

  • The lot or batch number of manufacture
  • The serial number of the device
  • The date of manufacture
  • The expiration date of the device
  • Any distinct identification code required by §1271.290(c) for the device

If you have questions about UDIs or UDI compliance, the experts at Arbour Group are here to help. We have a client base of over 250 pharmaceutical, medical and biotechnology clients across the globe, and are the leader in compliance assistance. Contact us today for more information on how we can assist your organization.

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.