Medical Devices

Overview

ICCBBA, the international standards organization responsible for the management and development of the ISBT 128 Standard, is a U.S. Food and Drug Administration (FDA) accredited issuing agency for Unique Device Identifiers (UDIs).

 

ISBT 128 UDIs apply to human cells, tissues, and cellular and tissue-based products (HCT/P) that are regulated as medical devices. The FDA website lists which HCT/P are regulated as biologics by CBER and which ones are regulated as medical devices by CDRH.

 

Why choose ISBT 128?

  • Traceability: The ISBT 128 Standard has been specifically designed to meet the special traceability needs of medical products of human origin (MPHO) to provide the donor to patient link of each product. In particular, it incorporates the identification of the donor within the standard to ensure this identification is globally unique and is presented in a standard format.
  • Identification: The globally unique Donation Identification Number (DIN) satisfies the FDA requirements for a distinct identification code as a production identifier (PI) for HCT/P.
  • Consistency: For HCT/P medical devices, there is a requirement to have a distinct identification code. With ISBT 128, this will always be the DIN.

 

The links on the left side of this page can be used to locate various materials that pertain to the use of ISBT 128 for FDA Unique Device Identification.

 


Click here for UDI-related material that pertains to UDI labelers.

 

Click here for UDI-related material that pertains to facilities that receive HCT/P medical devices.


 

Click here for an overview regarding the use of ISBT 128 for UDIs.