July 20, 2016

UDI Compliance

udi compliance

Ready to Meet UDI Requirements? We Can Help!

UDI ComplianceIn 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use.
A UDI (unique device identification) is a unique numeric or alphanumeric code that consists of two parts:

  • a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
  • a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
    • the lot or batch number within which a device was manufactured;
    • the serial number of a specific device;
    • the expiration date of a specific device;
    • the date a specific device was manufactured;
    • the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

All About the Data

Download PDF Although the label is the deliverable, achieving FDA UDI compliance is not just about the label. This is only one element in the complex process of managing data within the production process. Although it is easy to see how one might focus on the label due to the high percentage of voluntary recalls of medical devices caused by labeling and packaging defects, it is the data that is really the key issue. As you are aware, implications of product recalls are significant as the cost your company productivity, money and damage your ability to be efficient; not to mention the hit your company’s reputation can take.No need to worry! We strive to help you deliver safe, accurate and compliant product information. We will leverage our experience implementing these regulations with little interruption to your process. We will partner with you to make this transition seamless and have you compliant in no time!

Click the image to the left to read about our recent UDI Success with a large life sciences company.