FDA Issues Immediately-In-Effect Guidance on Unique Device Identification Policy Regarding Compliance Dates for Class I and Unclassified Devices

Today, the U.S. Food and Drug Administration released the immediately-in-effect (IIE) guidance document, "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices." This guidance will assist industry and FDA staff in understanding the Agency’s intentions regarding the enforcement of UDI requirements for certain class I and unclassified devices. It also aims to further explain the thinking behind FDA’s enforcement discretion policy for labeling, Global Unique Device Identification Database (GUDID) data submission, standard date formatting, and direct mark requirements for class I and unclassified devices, as first described in June 2017. Though this guidance document is immediately in effect, it remains subject to comment in accordance with the Agency’s good guidance practices. General comments on this and other Agency guidance documents are welcome at any time via electronic submission at www.regulations.gov. The guidance lists and explains several key elements of FDA’s enforcement discretion policy, including the Agency’s intention to: not enforce standard date formatting, labeling, and GUDID data submission requirements for class I and unclassified devices before September 24, 2020; not enforce direct mark requirements for class I and unclassified devices before September 24, 2022; and not enforce standard date formatting, labeling, and GUDID data submission requirements until September 24, 2021, and direct mark requirements until September 24, 2022 for finished devices manufactured and labeled prior to September 24, 2018. The enforcement policies described in the IIE guidance do not apply to class I and unclassified implantable, life-supporting or life-sustaining (I/LS/LS) devices, which had an established compliance date of September 24, 2015. If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100. For more information about the Unique Device Identification System, please visit the FDA’s UDI webpage. If you have any questions, please contact the FDA UDI Help Desk. Food and Drug Administration Center for Devices and Radiological Health