FDA Relaxes UDI Compliance Deadlines in New Guidance Document

By Rachael E. Hunt — On November 5, 2018, FDA issued its latest UDI policy “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” deferring enforcement of direct marking deadlines. The new guidance, effective immediately, supersedes the guidance issued in January, previously discussed here.  The guidance document is largely unchanged, other than with respect to direct marking deadlines, as noted below. Despite the best intentions, and unsurprisingly for industry, the implementation of FDA’s UDI system has been exceedingly complex. As a result, FDA is prioritizing its enforcement of various deadlines.  Specifically, FDA does not intend to enforce UDI direct mark requirements for Class III, life-saving or life sustaining, and Class II non-sterile devices that were manufactured and labeled prior to the UDI compliance deadline and remain in inventory, as…

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