FDA delays enforcement of certain UDI system requirements

The United States Food and Drug Administration (FDA) have delayed the enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

The FDA states that they do not “intend to enforce standard date formatting, labelling, and Global Unique Device Identification Database (GUDID) data submission requirements under Agency regulations for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under an Agency regulation for these devices before September 24, 2022.”

The guidance does not apply to implantable, life-supporting or life-sustaining devices (I/LS/LS). For class II, class III and I/LS/LS devices, the compliance dates established for most UDI requirements have passed.

The plan for a seven-year phase-in of the requirements, which has been pushed back, follows established compliance dates based primarily on device classification.

To view the UDI policy regarding compliance dates for class I and unclassified devices, please click here.