Extension Letter to Class III Contact Lens and Intraocular Lens Labelers - August 15, 2014
Dear Class III Contact Lens and Intraocular Lens Labelers:
Effective August 15, 2014, the FDA’s Center for Devices and Radiological Health (CDRH) is granting a 1-year extension of the September 24, 2014 Unique Device Identification System (UDI) compliance date for the following class III medical devices:
|Device||Product Code||Classification Regulation|
|Rigid Gas Permeable Contact Lens (extended wear)||MWL||21 CFR 886.5916(b)(2)|
|Orthokeratology Contact Lens|
|Soft (hydrophilic) Contact Lens|
|LPM||21 CFR 886.5925(b)(2)|
|Intraocular lens (IOL)||HQL||21 CFR 886.3600|
|Multifocal Intraocular lens||MFK|
|Accommodative Intraocular lens||NAA|
|Toric Optics Intraocular lens||MJP|
|Phakic Intraocular Lens||MTA|
|Iris Reconstruction Lens||NIZ|
On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule). The UDI 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 will be phased in over a 7-year period through an established set of compliance dates. The compliance date for class III devices is September 24, 2014.
Recently, certain labelers of the contact lens and IOL industries notified the FDA of a UDI labeling strategy being employed for these devices that would result in an extremely large number of data submissions to the Global Unique Device Identification Database (GUDID). Not only would the volume of submissions greatly exceed the best estimates previously available to the FDA, we have also learned that many of these submissions would be virtually identical files. Pursuant to 21 CFR 801.55(d), the FDA has determined that initiating and granting a 1-year extension would be in the best interest of the public health. This additional time will allow the FDA to work with the affected labelers to develop an approach to ensure that meaningful data will be submitted to the GUDID.
Therefore, labelers of devices listed above are now provided a new UDI compliance date of September 24, 2015. The extension applies to the requirements to provide a UDI on the device label and packages, format dates on the device label according to 21 CFR 801.18, and submit data to the GUDID. Some labelers may have already implemented the UDI label and date format requirements for these devices. In such cases, this extension would only apply to the requirement to submit information to the GUDID.
For additional information, please contact the FDA UDI Help Desk.
Thomas P. Gross, MD, MPH
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration