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:

• Are non-sterile;
• Were manufactured and labeled before September 24, 2022;
• Remain in manufacturers’ inventories but do not have non-UDI marks that provide access to full UDI data.

Updated compliance dates

Also included under the new guidance are clarifications to UDI direct mark compliance deadlines. Specifically:

• Non-implantable, non-life-supporting and non-life-sustaining devices requiring direct marks and that were manufactured and labeled before their label compliance dates will not have to obtain direct marketing until one year following their direct marketing compliance deadlines.
• Such devices that were manufactured after their label compliance dates but prior to their direct mark compliance dates will not receive a one-year grace period and must be directly marked by their established compliance dates.

Adjusting UDI direct marking policy is intended to expand UDI benefits to medical devices that have remained in manufacturers’ inventories without adding additional cost burdens, which may otherwise prompt some companies to dispose of these devices; such a move would potentially create shortages of some devices, according to FDA.

Related FDA UDI regulatory resources from Emergo by UL:

• Medical device Unique Device Identification (UDI) consulting and training
• US FDA 510(k) consulting for medical device and IVD companies
• Video overview: Introduction to the US FDA UDI system
• Whitepaper: Understanding the US FDA UDI regulation