On Friday, June 2, Thomas P. Gross, MD, MPH, Director of the Office of Surveillance and Biometrics, CDER, penned a letter explaining that the agency plans to extend compliance dates for the unique device identification system (UDI system) requirements for certain class I and unclassified devices that generally present a lower risk to patients, such as manual surgical instruments and mechanical wheelchairs.
He acknowledged the need for robust integration of UDI data throughout the healthcare system, and announced plans “to engage with industry and other stakeholders to address existing challenges and optimize the quality and utility of the data for higher-risk medical devices already in the system before adding lower-risk medical devices.”
FDA will issue a guidance document that will provide the requirements that must be met by the new compliance dates:
September 24, 2020 for Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18) Requirements
September 24, 2022 for Direct Mark (21 CFR 801.45) Requirements
As Dr. Gross wrote, “With successes come challenges, and implementing UDI is no exception. For example, after fully considering the time needed to meet UDI requirements, many labelers asked FDA for extensions to comply. In addition, we identified complex policy and technical issues that need resolution, such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments. Providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices.”