Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff





FDA Issues Guidance Updating Unique Device Identification Compliance Policy



Today, the U.S. Food and Drug Administration (FDA) released the guidance, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking," which takes effect immediately. This document includes updated guidance on Unique Device Identification (UDI) direct mark requirements. It also supersedes a guidance issued in January 2018, which outlined the FDA’s compliance policy for UDI label, date format, and direct mark requirements for class I and unclassified devices. 

What Has Changed?
The new guidance provides additional FDA policy on enforcing UDI direct mark requirements for non-sterile devices requiring a UDI direct mark that were manufactured and labeled before their applicable direct mark compliance date provided the device bears a non-UDI direct mark and the labeler has developed a method by which, using the non-UDI mark, the full UDI may be made available. For class I and unclassified devices (other than life-supporting or life-sustaining devices), whose direct mark compliance date is September 24, 2020, the FDA does not intend to enforce UDI direct mark requirements until September 24, 2022); additionally, after that date, the FDA does not intend to enforce UDI direct mark requirements for such devices that are non-sterile, were manufactured and labeled prior to September 24, 2022, and remain in inventory but bear a non-UDI mark from which the full UDI may be made available.

This guidance also clarifies certain direct mark compliance dates. Medical devices that are not implantable or life-supporting or life-sustaining but which require a direct mark and were manufactured and labeled prior to their label compliance date do not need to be directly marked until one year after their direct mark compliance date. However, devices which require a direct mark that were manufactured after their label compliance date but before their direct mark compliance date do not get a one year grace period and must be directly marked as of the direct mark compliance date, based on the established compliance dates.

What Prompted the Change?
This policy is in response to industry concerns that reworking devices in inventory to comply with UDI direct mark requirements would be a costly burden. By changing the previous policy, there may still be some achievement of the benefits of UDI for devices that have remained in inventory while reducing the risk that industry will choose to avoid the cost of remediation by discarding inventory and potentially creating device shortages. Though this guidance document is in effect immediately, it is available for comment. General comments on this and other Agency guidance documents are welcome at any time through electronic submission at www.regulations.gov.

Questions?
If you have any questions regarding this guidance document, please contact the Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by 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