UDI Final FDA Guidance


FDA Final Guidance on Unique Device Identifier (UDI) posted July 7, 2021, a PDF copy of the guidance is available at the following Link:  UDI Final Guidance

Specifically, this guidance describes the requirements for and FDA’s recommendations regarding the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013).

Performance Validation assisted a large medical device manufacturer implement UDI requirements using TrackWise® as a software solution – to learn more check out our project summary.

For more information about Performance Validation, Computer System Validation, or our UDI project(s), contact:

Kevin Marcial

Performance Validation, CSV Services Manager
Principal Validation Specialist