EMERGO SUMMARY OF KEY POINTS:
- US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices.
- UDI policy changes were prompted to assist manufacturers manage compliance for devices in inventory and avoid potential device shortages.
The US Food and Drug Administration has revised its Unique Device Identification (UDI) regulation’s direct mark requirements and compliance deadlines in response to cost and inventory concerns raised by industry.
In new, immediately effective guidance, FDA updates UDI direct mark requirements for certain types of non-sterile devices, Class I devices as well as unclassified devices. The guidance also clarifies some direct mark compliance timeframes and grace periods.
Medical device types affected by UDI revisions, and how
The new FDA guidance pertains to UDI direct mark requirements for the following device types:
Non-sterile devices requiring UDI direct marking: The guidance expands policies for such devices manufactured and labeled prior to their direct mark compliance deadlines, assuming these devices have non-UDI direct marks as well as labels designed so that full UDI information is available by using those non-UDI direct marks.
Class I and unclassified devices: For such devices that do not function as life-supporting or life-sustaining products with direct mark compliance dates of September 24, 2020, FDA will delay enforcement of UDI direct mark requirements to September 24, 2022. Following that enforcement deadline, the agency will not enforce UDI direct mark rules for Class I and unclassified devices that…