The U.S. Food and Drug Administration (FDA) has extended the deadline for certain low-risk medical devices to comply with its unique device identification (UDI) requirements.
In a June letter to medical device companies, Thomas Gross, the Director of the FDA’s Office of Surveillance and Biometrics noted the success to date in the implementation of UDI requirements applicable to higher-risk Class II and Class III medical devices, citing the more than 1.4 million UDI records already submitted to the FDA’s Global Unique Device Identification Database (GUDID). However, the sheer volume of submissions, along with new questions about the application of the requirements to certain types of low-risk devices, as well as the integration of UDI information into electronic health information systems, has prompted the FDA to extend UDI compliance dates for Class 1 and unclassified medical devices.
According to Gross’s letter, Class 1 and unclassified devices will now need to submit UDI data for inclusion in the GUDID by September 24, 2020, and meet direct mark requirements by September 24, 2022. The FDA is also expected to issue a guidance document that will provide further clarification on its UDI requirements for these devices.