FDA Grants UDI Extension for Soft Contact Lenses

March 31, 2017

Effective March 30, 2017, FDA is granting an extension for labelers of soft (hydrophilic) contact lenses to comply with the requirements of the Unique Device Identification (UDI) system.

On September 24, 2013, the FDA published a final rule establishing a UDI system. The rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies.

The rule is being phased in over a 7-year period according to an established set of compliance dates. The compliance date for class II devices was September 24, 2016.

However, the FDA said that based on the current industry practice of assigning a different device identifier to each prescription, submission of soft contact lens information would produce a large number of virtually identical records. As a result, the FDA is delaying UDI rule requirements for soft contact lenses until one year after it finds a technical solution to the problem.

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