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Lens Makers May Resume GUDID Submissions

July 17, 2015

The FDA is giving labelers of intraocular lenses the green light to restart submissions to the Global Unique Device Identification Database after extending the deadline by one year over data concerns.

To ensure that IOL information in the GUDID database is meaningful, the agency is asking labelers to include descriptive information about their lenses — such as cylinder power, optical diameter and diopter. Doing so, the FDA hopes, will ensure there is enough variation between the device identifiers to differentiate between versions and models. IOLs are used after the natural lens is removed, typically after cataract surgery.

The FDA’s recommendation comes after the agency granted labelers an extension from the original Sept. 24, 2014, UDI deadline for certain Class III devices, citing worries over the sheer volume of device identifiers that would be loaded into the database. Industry also expressed concern that many of the submissions would be virtually indistinguishable from each other.

The FDA received more information from industry and determined the labeling strategy being employed would lead to only a “relatively small number” of submissions to the GUDID. The notice reminds companies to submit the DI records by the Sept. 24, 2015, deadline. — Elizabeth Hollis