FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices

EMERGO SUMMARY OF KEY POINTS:

• US FDA has published guidance setting new UDI compliance deadlines for some Class I and unclassified medical devices.
• The new deadlines were initially proposed in summer 2017.

The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk medical devices.

New guidance from the regulator establishes deadlines initially discussed in June 2017 according to coverage by Emergo. The extended deadlines apply to the following cases:

• For Class I and unclassified devices manufactured and labeled on or after September 24, 2018, FDA will not enforce UDI labeling, Global Unique Device Identification Database (GUDID) data submission or Standard Date Format requirements until September 24, 2020. Direct Mark requirements will not go into effect for these devices until September 24, 2022.
• For finished Class I and unclassified devices manufactured and labeled before September 24, 2018, the agency will begin enforcing UDI labeling, GUDID data submission and Standard Date Format requirements on September 24, 2021; the new deadline or Direct Mark requirements will be September 24, 2022.

As noted by FDA in previous discussions, these UDI compliance extensions do not apply to devices with implantable, life-supporting or life-sustaining features.

Related FDA UDI regulatory resources from Emergo:

• Medical device Unique Device Identification (UDI) compliance consulting and training
• FDA 510(k) consulting for medical device and IVD companies
• Video overview: Introduction to the FDA UDI system
• Whitepaper: Understanding FDA UDI requirements