EMERGO SUMMARY OF KEY POINTS:

• US FDA UDI compliance deadlines for Class I low-risk medical devices have been exteneded to September 2020.
• Direct UDI marking requirements will go into effect in September 2022 for low-risk devices.
• The extension is necessary for the FDA to address various technology and policy challenges raised as Class II and III medical devices have come into compliance with the new UDI system.

US Food and Drug Administration medical device regulators have extended Unique Device Identification (UDI) labeling and related compliance deadlines for lower-risk devices to late 2022 in order to fully standardize and optimize UDI data already collected on high-risk devices.

According to a notice to Class I and unclassified device registrants, UDI requirements already in force for many Class II and Class III devices have yielded 1.4 million records submitted to the FDA’s Global Unique Device Identification Database (GUDID) as of May 1, 2017. However, UDI implementation for higher-risk devices has also created tricky technical and policy challenges for both FDA regulators and registrants. Extending UDI labeling timelines for low-risk devices will allow the agency to address and remedy these challenges before even more data is submitted to GUDID.

New deadlines for Class I UDI compliance: September 2020 and September 2022

The FDA plans to issue new guidance covering enforcement discretion for low-risk medical device UDI labeling, GUDID submission, standard date formatting and direct mark obligations.

Class I and unclassified devices will have to meet UDI labeling, GUDID data submission and standard date formatting rules by September 24, 2020. Direct mark requirements under 21 CFR Part 901.45 will have to be met by September 24, 2022 for these low-risk devices.

The new deadlines do not apply to Class I or unclassified devices that are implantable, life-supporting or life-sustaining.

Related FDA UDI resources from Emergo:

• FDA medical device UDI consulting support
• FDA 510(k) premarket notification support for medical device companies
• Video overview: US FDA UDI system
• Whitepaper: Understanding US FDA UDI requirements