FDA grants extension for Unique Device Identification compliance

The FDA is granting an extension for soft contact lens labelers to comply with the requirements of the Unique Device Identification system, which was established Sept. 24, 2013.

The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution is the U.S., unless an exception or alternative applies, the letter from the FDA stated.

The rule is being phased in over a 7-year period according to an established set of compliance dates.

The FDA has previously granted two extensions for the soft contact lens industry.

The first, dated Aug. 15, 2014, granted a 1-year extension of the Sept. 24, 2014, compliance date for class III soft contact lens devices.

The second, dated Oct. 6, 2015, granted an additional 2-year extension for class III soft contact lens devices and a 1-year extension of the Sept. 24, 2016, compliance date for class II soft contact lens devices.

The extensions granted by the second letter expire on Sept. 24, 2017, according to the FDA.

The FDA granted these extensions as submission of soft contact lens information to the Global Unique Device Identification Database (GUDID), based on the current industry practice of assigning a different device identifier to each prescription, would have resulted in an exceptionally large number of virtually identical DI record submissions.

The extension applies to labelers of: soft (hydrophilic) contact lens (for extended wear), soft (hydrophilic) contact lens (for color vision deficiency), soft (hydrophilic) contact lens (for reading discomfort), soft (hydrophilic) contact lens (for daily wear) and soft (hydrophilic) contact lens (disposable).

Some soft (hydrophilic) contact lens labelers have already implemented the UDI label and date format requirements for these devices; in these cases, the extension would apply only to the requirement to submit information to the GUDID.

Source: www.fda.gov