FDA Delays UDI Enforcement for Some Lower-Risk Devices


Posted January 16, 2018

The Food and Drug Administration (FDA) has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk medical devices by at least two years, according to a Jan. 16 guidance document. These requirements were originally scheduled to be enforced starting this fall.

For Class I and unclassified medical devices manufactured and labeled on or after Sept. 24, 2018, UDI labeling, standard date format, and Global Unique Device Identification Database (GUDID) data submission requirements will not be enforced until Sept. 24, 2020. Finished Class I and unclassified devices manufactured and labeled prior to Sept. 24, 2018 will get an extension until 2021. Direct mark requirements for these devices—a requirement that the UDI is placed directly on a reusable device that is reprocessed between uses—will be pushed back until 2022.

The extensions do not apply to devices with implantable, life-supporting, or life-sustaining features, as the compliance dates for those devices, as well as higher-risk Class II and Class III devices, passed in 2015.

The FDA attributed the delay in enforcement to the difficulties implementing UDI requirements for higher-risk devices. The FDA has identified “complex policy and technical issues” that still need to be resolved in order to provide high-quality data for the system to work as intended.

“To fully reap the public health benefits and a return on investment of the unique device identification system, the agency intends to focus its resources on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices,” the FDA wrote in the guidance. “Undertaking this endeavor now will help ensure the transition from development of the [UDI] system to widespread use and sustainability.”

The FDA’s UDI rule was developed to better track medical devices throughout their life cycle through the use of identification numbers (usually on the device’s label) and that are tracked in an online database (GUDID). FDA’s published a final rule in 2013 that established the UDI system with an expected seven-year phase-in period based on a device’s classification. However, manufacturers reported that they were struggling to meet UDI requirements in 2016, prompting the FDA to provide additional guidance on how the required information should be ordered.

While the current FDA guidance goes into effect immediately, public comments can still be submitted online at www.regulations.gov.