Medical Products of Human Origin, UDI and ICCBBA: Supply Chain’s Role

By AHRMM

Some Human Cellular Tissue Products (HCTP) are considered “devices” and will require their assigned Unique Device Identifiers (UDI) to be tracked within the patient’s Electronic Health Record (EHR) and shared across the healthcare spectrum. Supply chain should be having interdepartmental conversations to determine how they will handle these types of products and their UDIs.

Related Resources

Request for Proposals (RFP)
General Contractor RFP
A sample of a general contractor RFP.
Letter/Comment
AHRMM Comment Letter to FDA Regarding the Draft Guidance for Industry on the Global Unique Device Identification Database (GUDID)
On November 21, 2013, AHRMM submitted electronically
Toolkits/Methodology
Guidance for Writing Comments
How to write a constructive, information-rich comment that clearly communicates and supports its claims to have an impact on regulatory decision…