The new math is UDI = DI + PI.
Class II and Class III devices will require both a device identifier (unique to the specific item) and production identifier (unique to the model or version) which will be presented as a barcode and text description. Class I devices and devices expect from GMP (good manufacturing practice), such as bed pans, will require only the production identifier.
Where necessary, devices such as reusable surgical instruments and implants will be marked on the device. Standalone software that is not an integral part in a medical device will be required to display the production identifier when run.
What makes a model a model? Standard manufacturer methods for determining when a model has change can be used to determine this, with some exceptions:
• A change in the specifications, performance, size, or composition of the device to an extent greater than the specified limits requires the device to receive a new UDI.
• A change to the device package (for example, from a package containing 10 devices to one containing 12) or the addition of a new device package would entail a new UDI.
• A change that could significantly affect the safety or effectiveness of the device would require a change in the UDI.
• A change from sterile to non-sterile (or vice versa) would require a change in UDI.
• A device that is relabeled (with a change to a label that entails more than an addition of information such as a distributor’s name and contact information) would need to receive a new UDI. [Source: Eastern Research Group Lexington, MA]
Code included in the UDI
(01) Device unique identification
(21) Serial Number
(11) Manufacture date
(17) Expiration date
(10) Lot number
Compliance Dates:
10/24/2015 - Life Sustaining and Life Supporting devices (Extended 8/14/15 by FDA notice)
9/24/2016 - Class III devices and devices licensed under Public Health Services Act
9/24/2018 - Class II devices
9/24/2020 - Class I devices and unclassified devices
Open Questions:
21 CR 801.45(b) states that a device package and device may have different UDI labeling. If we are reading this correctly, should we be advising user to read the UDI only from the actual device?
Terms:
Global Trade Identification Numbers (GTIN) - GS1
Sources:
The Brookings Institution Washington, DC
Eastern Research Group Lexington, MA
Access GUDID at nih.gov
U.S. Department of Health and Human Services, Draft, Unique Device Identification: Direct Marking of Devices, June 26, 2015
