UDI Compliance Date Extended for Class III Contact Lens and Intraocular Lens Labelers

Extension Letter to Class III Contact Lens and Intraocular Lens Labelers

August 15, 2014

FDA issues the following letter.

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
(Overnight)
NUU
Soft (hydrophilic) Contact Lens
(extended wear)
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.

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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.

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UDI Compliance Dates for the UDI Final Rule

Compliance Date Requirement
1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (September 24, 2016) Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class II medical devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
5 years after publication of the final rule (September 24, 2018) A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule (September 24, 2020) Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.

Last Updated: 2015-12-30

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