The Unique Device Identification (UDI) system is a globally recognized system for identifying and tracking medical devices throughout their distribution and use. It was established by the US Food and Drug Administration (FDA) to enhance patient safety and improve the efficiency of medical device recalls.
For class 1 medical devices, which are considered low risk devices, the UDI requirements are more flexible than for higher risk devices. Class 1 devices are exempt from the requirement to include a UDI on the device label if they are exempt from GMP regulations.
FDA has categorized Class 1 devices in two categories.
- Class 1 devices that are considered as consumer health products.
- Class 1 devices that are not considered as consumer health products.
Class 1 devices that are considered as consumer health products are the devices that pose the lowest risk of which many are 510(k)-exempt devices are sold directly to consumers over-the-counter in retail and online stores. Since these devices pose the lowest risk, FDA does not intend to enforce GUDID submission requirements under consumer health products.
Class 1 devices that are not considered as consumer health products are the devices that are typically used in healthcare settings and are often subject to additional regulatory controls, such as 510k submission. Submission of UDI for these devices will be helpful in reducing medical errors and simplify the integration of device use information into data systems.
Below are the compliance dates for class I medical devices.
| Device Type | Compliance Date |
| Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI | September 24, 2022 |
| Class I and unclassified devices, other than I/LS/LS devices | September 24, 2022 |
| Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI | December 8, 2022 |
The UDI for class 1 medical devices must be in a human-readable format and a machine-readable format, such as a barcode or RFID tag. The UDI must also be submitted to the FDA’s Global Unique Device Identification Database (GUDID), which is a publicly accessible database that contains information on medical devices.
The UDI system helps to ensure the safety and effectiveness of medical devices by enabling more accurate tracking and monitoring of these products throughout their lifecycle.
Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.
Sudha S
Regulatory Consultant
Email: Office@libertymanagement.us