August 7, 2012
By Pam Davol, Clinical & Regulatory Project Manager
What is the FDA’s Unique Device Identification System?
The Unique Device Identification (UDI) System is a new regulation to be imposed by the FDA that requires the labeling of medical devices and medical device constituents (i.e. device components of combination products) to bear a unique identifier, which will adequately identify the device through distribution and use, and may include information on the lot or serial number.
Who will be affected by the new UDI regulation?
The UDI regulation applies to medical device manufacturers.
To which devices does the new UDI regulation apply?
The UDI regulation applies to Class I, Class II and Class III devices manufactured for clinical use or sale in the United States. Several general exemptions apply;
How does the UDI System work?
The FDA will maintain the Global UDI database to which manufacturers will submit detailed information about the individual product identified.
What information is the UDI code required to contain?
Exemptions from the UDI regulation:
Detailed information to be submitted to the UDI Global database:
There are two parts to the UDI code: the Device Identifier and the Production Identifier.
The Device Identifier identifies a specific manufacturer’s version, make or model of a device, and it is analogous to an NDC number or UPC code. This information is
The Production Identifier provides the control information for the device such as the lot number, expiration date, a serial number or some other identifying information used by the manufacturer. The UDI regulation requires additional information if the label includes an expiration and/or manufacture date;
When will manufacturers need to implement the new UDI System requirements?
Additional information required if a label includes an expiration and/or manufacture date:
Requirements for implementation will be based on the device premarket risk class as follows:
Note: UDI code requirements do not apply to devices that are already in distribution at the time these requirements go into effect.
Class III (ex. implants)– 12 months after final rule published
Class II (ex. equipment) – 36 months after final rule published
Class I (ex. disposables) – 60 months after final rule published
Direct part marking requirements are effective 2 years after class effective date
How do the new UDI system requirements apply to combination products having a device constituent?
A UDI code is required for each device and each constituent of a combination product if:
Do the new UDI System requirements apply to device kits?
Yes, UDI regulations also apply to medical device kits.
If a manufacturer is distributing a group of medical devices as a surgical kit, the kit itself would need its own UDI and each part, or each device within that kit would also need its own UDI. The exception would be if any devices within the kit are intended only for single use, then that single-use device would not need its own UDI.
What about those devices that are primarily dispensed through pharmacies, such as diabetes care products, which to date have carried either NDC (National Drug Code) or NHRIC (National Health Related Item Code) numbers. Do the UDI code requirements apply?
As the effective date comes into play for their respective class of device, manufacturers will no longer be allowed to use these national numbering systems. The FDA will be phasing out the use of NDC or NHRIC numbers completely for all medical devices with the implementation of the UDI.
To learn more about FDA’s UDI System.