In June of 2014 the FDA published the Global Unique Device Identification Database (GUDID) Guidance, or simply referred to as the UDI.
All medical devices will be subject to this new guidance by September 2020, but there is a schedule in the guidance broken down by specific device classifications, most of which need to be compliant far before that date.
Global Unique Device Identification
The goal of the UDI is essentially to come up with a global unique device identification system establishing a specific number for each device and each configuration that is marketed to the public.
The UDI is assigned through accredited issuing agencies.
There are currently three issuing agencies:
- GS1 (GS1 Healthcare US, found at https://www.gs1us.org)
- HIBCC (Health Industry Business Communications Council, found at https://www.hibcc.org)
- The ICCBBA (International Council for Commonality in Blood Banking Automation, found at https://www.iccbba.org)
These organizations are all NGOs, or non-governmental organizations, which are neither part of the government nor conventional for-profit businesses.
UDI Requirement
Every medical device and medical device package is required to have the UDI on the labelling with specific formatting requirements.
This includes stand-alone medical device software and convenience kits (kits of various components that provide convenience to the end-user by having all the components necessary in a single product offering).
Two Parts
The UDI is composed of two parts, the first being the DI, or Device Identifier.
This is a fixed value used to identify the labeller of the device and the specific model of the device.
The second part is the PI, or Product Identifier, which is variable and identifies the lot/batch number or serial number (whichever is applicable), the expiration date (in the format of YYYY-MM-DD), the date of manufacturer, and for human cells, tissues and cellular and tissue based products the distinct code required by 21 CFR 1271.290.
