FDA Unique Device Identifier (UDI)

FDA has established a unique device identification system to adequately mark and identify medical devices through their distribution and use (in human readable plain text and machine readable formats like AIDC technology). A UDI is required on device labels and device packages, and in some cases on the devices themselves, unless there is an exception or alternative granted by the FDA. The UDI needs to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed between uses. The permanent UDI may be in plain text, AIDC technology, or both.

  • The label of every medical device (including all IVDs) must have a UDI, Class I cGMP exempt devices do not need to be labeled with a UDI.
  • Every device package must have a UDI.
  • Devices within co-packaged combination products that bear an NDC are required to bear a UDI on its label.
  • Stand-alone software must bear a UDI on its label and device packages as well as on a startup screen.
The UDI is composed of two parts, Device Identifier (DI) and Product Identifier (PI).

DI (Mandatory, fixed portion of UDI)

  • DI Identifies the labeler and the specific version or model of a device
  • DI assigned to a specific Medical Device version or model never changes.
  • New DI is required for new version or model

PI (Conditional, variable portion of UDI)

  • PI includes lot, batch, serial number, expiration date, date of manufacture, and distinct identification code (If any)
  • PI will change for each lot or batch
  • When certain information is on the label it should be in the UDI as well. (except for Class 1 devices)

FDA has accredited three Issuing Agencies (GS1, HIBCC and ICCBBA) that conform to international standards to assign UDI. Labelers can contact any accredited Issuing Agency to get the UDI. The fees for UDI assignment for each agency is different.

GUDID Submission:

The GUDID (Global Unique Device Identifier Database) is a database which contains device identification information. The GUDID contains only the DI portion of UDI. PI parts are not submitted to or stored in the GUDID.

The compliance dates for GUDID submissions are as follows:

(1) Class III Medical Devices - September 24, 2014

(2) Implantable, Life-Supporting and Life-Sustaining Devices - September 24, 2015

(3) Class II Medical Devices - September 24, 2016

(4) Class I and Unclassified Medical Devices - September 24, 2018

LMG provide Assistance in :

  • Selection of accredited UDI Issuing agency suitable for your requirements
  • GUDID Submission