July 10, 2020
Final guidance from the US Food and Drug Administration pushes back enforcement deadlines for certain Unique Device Identification (UDI) requirements for Class I and unclassified medical devices due partially to the agency’s coronavirus pandemic-related priorities.
According to the final guidance, FDA will delay enforcement of UDI labeling, date formatting as well as Global Unique Device Identification Database (GUDID) submission requirements for Class I and unclassified devices until September 24, 2022. Enforcement of compliance deadlines for these requirements had previously been set for September 24, 2020.
Reasons for UDI enforcement delay
In 2018, FDA announced that it did not plan to enforce standard date formatting, UDI labeling and GUDID submission requirements until September 2020 Class I and unclassified devices; direct UDI marking for such devices would be enforced starting September 24, 2022.
These enforcement delays were intended so that the agency could focus on addressing UDI implementation challenges for Class II and Class III device manufacturers, as well as for implantable, life-supporting and/or life-sustaining devices, all of which had more aggressive UDI compliance deadlines to meet.
In 2020, the agency has also had to divert substantial resources to address the COVID-19 public health emergency, further necessitating UDI enforcement delays for lower-risk devices.
Direct mark compliance for low-risk devices
In addition, the final guidance addresses FDA’s enforcement plans for UDI direct mark requirements for low-, moderate- and high-risk devices.
Regarding Class II and Class III devices as well as implantable, life-saving and/or life-sustaining devices, FDA does not plan to enforce UDI direct mark requirements under previously established deadlines in cases where a device’s UDI data may be derived from other directly marked on the product.
For Class I and unclassified devices, UDI direct mark requirements had been set to take effect on September 24, 2020; according to the final guidance, FDA will not enforce these requirements sooner than September 24, 2022.
Learn more about FDA UDI requirements for medical devices:
- Medical device UDI consulting and training
- US FDA submission support for medical devices and IVDs
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