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Labels for human cells, tissues, and cell- or tissue-based products (HCT/P) that are regulated as devices must meet labeling requirements for both biologics and medical devices. ISBT 128, one of the three standards that may be used for UDI, was specifically designed for coding and labeling of HCT/P. This presentation will discuss how ISBT 128 can meet labeling requirements for both biologics and medical devices.

The presentation will include:
  • What makes HCT/P different from other medical devices
  • The use of the Donation Identification Number to meet the requirements of a distinct identifier in 1271.370
  • Standardized product coding as an element of the DI
  • Live Q & A
About the Presenters:

Jay Crowley

Vice President of Unique Device Identification Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

Pat Distler

Technical Director, ICCBBA Pat has worked for International Council for Commonality in Blood Banking Automation, Inc. (ICCBBA), the organization that manages the ISBT 128 information standard, for 10 years.

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