In September 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, which requires most medical devices to carry a UDI. A UDI is a numeric or alphanumeric code consisting of a device identifier (DI) and a production identifier (PI) that must be placed on the device label and on the device packaging. The labeler is responsible for complying with this rule.
Compliance Deadlines
The compliance deadlines for Class II devices and for Class III devices have already passed. In June 2017, FDA informed industry that it intended to extend the compliance deadline for these devices due to complex policy and technical issues, among other things. In January 2018, the Agency issued a guidance document detailing how it would utilize its enforcement discretion:
- For Class I and unclassified devices manufactured and labeled on or after September 24, 2018, FDA intends to enforce: -UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2020. -Direct Marking requirements beginning September 24, 2022.
- For finished class I and unclassified devices manufactured and labeled before September 24, 2018, FDA intends to enforce: -UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2021. -Direct Marking requirements beginning September 24, 2022.
