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.
- 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.