Unique Device Identification (UDI) System Information

The FDA has published the final rule implementing the requirement for Unique Device Identification (UDI) System implementation by manufacturers. The rule has an impact on the labeling and tracking of medical devices. The final rule impacts several FDA regulations (CFR), one being the Medical Device Quality System Regulation or Good Manufacturing Practice (21 CFR Part 820). The changes to 21 CFR Part 820 simply add the requirements associated with UDI implementation and do not affect the rest of the Quality System Regulation. Below are several important links to information pertaining to the UDI implementation and final rule.

UDI Final Rule published in the Federal Register September 24, 2013. The pages proceeding the actual final rule are called the Preamble and provide insight into FDA's rationale for various parts of the rule. The final rule and revisions to other parts of the CFR (Code of Federal Regulations) such as 21 CFR Part 820 are found in the last sections of this document.

Current Quality System Regulation (21 CFR Part 820) including the UDI revisions

FDA's UDI home page

UDI QSR/GMP Revision Sheet for Noblitt & Rueland Quality System Regulation Pocket Reference

CONSULTING & TRAINING: If you would like consulting assistance or in-house training regarding the implementation of revisions to your Quality System to comply with the UDI required regulation or in complying with the UDI regulations in general, please let us know.