The United States Food and Drug Administration (FDA) published a final rule in 2013 which outlined additional labelling requirements for manufacturers of Medical Devices being supplied in the United States in an attempt to improve the trace-ability. This introduced the Unique Device Identifier (or now known as the UDI) to manufacturers around the world.
The UDI is a numeric or alphanumeric code that is issued and managed through an FDA accredited agency. Companies have a choice from three accredited agencies (GS1, HIBCC and ICCBBA) for support, implementation and most importantly data validation.
In its simplest terms, the UDI consists of two parts being the Device Identifier (DI) and the Product Identifier (PI). The DI is made up of information including product models/catalogue numbers and version. The production identifier (PI), a conditional, variable portion of a UDI identifies one or more of the following when included on the label of a device:
- the lot or batch number within which a device was manufactured;
- the serial number;
- the expiration date;
- the date a specific device was manufactured;
- the distinct identification code required by for a human cell, tissue, or cellular and tissue-based product which is regulated as a device.
The UDI allows full traceability throughout the distribution of the product. UDI numbers will be part of a pool of data collected and published via the accredited agencies within the Global Unique Device Identification Database (GUDID). Although there is a substantial amount of data published, the PI is not used within the GUDID as the information is specific to the actual device being distributed.
Timetable for Implementation
Implementation of the labelling requirements is staged over several years starting with the highest risk devices (Class lll) in 2014
All deadlines include a requirement where devices that are labelled with a UDI must be submitted to the Global Unique Device Identification Database (GUDID). In collaboration with the National Library of Medicine, the FDA created a portal which makes device identification information available for everyone–including patients, caregivers, health care providers, hospitals, and industry. The GUDID will not include any personal data.
- By September 24, 2014
- the UDI must be included for device labelling and packaging on all Class lll medical devices and devices licensed under the Public Health Service Act. There is also an option to gain a 1-year extension.
- By September 24, 2015
- UDI must be implemented for implantable, life-supporting, and life-sustaining devices.
- By September 24, 2016
- Manufacturers of Class III devices will need to have product labelled with a permanent marking UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
- The Class ll devices that are NOT included in UDI extension letter to device labellers (issued Sept 6th) must bear a UDI label and meet the various labelling requirements.
- By September 24, 2018
- Multiple use, re-processable and some other class II devices to be labelled with a UDI as a permanent marking on the device itself.
- Class I medical devices and devices that have not been classified must also include a UDI.
- By September 24, 2020
- Class l devices that are intended to be used more than once and intended to be reprocessed will be required to include the UDI as a permanent marking on the device itself.
Additionally to the implementation of the UDI is the requirement where the device labelling shall meet the US FDA regulation 801.18 where the date must also be presented in a specific format unless otherwise indicated.
Need help with your device labelling requirements? Be sure to meet the Brandwood Biomedical team at RAPS or ensure you join the labelling session………. Let’s talk about how we can support you. Email firstname.lastname@example.org or call our office on +61 2 9906 2984.