UDI Requirements for Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) Devices

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 6

Jay Crowley, Vice President of UDI Services and Solutions, USDM Life Sciences

Jay is the Vice President of UDI Services and Solutions at USDM Life Sciences. 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 ICCBBA 3

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. In this position. She manages the technical documentation and provides user support to blood banks, tissue banks, cellular therapy facilities, and milk banks around the world in support of their efforts to implement ISBT 128.

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  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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