As you probably know by now, FDA’s deadline for Unique Device Identification (UDI) depends on device class. Class III device labelers had until September 2014 to comply, followed by Implantable, Life-Supporting, Life-Sustaining devices in 2015 and Class II devices in 2016. 2018 will bring the deadline for Class I, the lowest risk category for devices on the U.S. market.
2017 is somewhat of a gap year for UDI implementation. This gives Class II labelers who have not yet complied a chance to catch up (though they could face serious enforcement actions by FDA in the meantime) and Class I labelers a chance to get the ball rolling.
Until recently, the FDA’s UDI implementation timeline called for all contact lenses to fall under UDI requirements in September of this year. Though contact lenses are classified as either Class III or II devices (depending on FDA product code), the agency issued extensions to soft and rigid gas permeable contact lens labelers to September 24, 2017. These extensions were due to the fact that FDA anticipates an “extremely large number of data submissions” of contact lens Device Identifier records to the FDA Global UDI Database (GUDID).
On March 30, 2017, FDA delayed the UDI deadline for soft contact lenses to a future undetermined date while the agency develops “an approach that ensures that meaningful data will be submitted to GUDID.” However, it is very important for affected labelers to understand that the September 24, 2017 deadline for rigid, gas-permeable contact lenses remains unchanged.
The 2017 deadline applies to four FDA product codes—two for daily use (HQD and MUW) and two for extended wear (NUU and MWL). The data field requirements for these types of contact lenses are the same as those applied to all other types of Class III and Class II devices.
Labelers facing the September 2017 deadline should consider very carefully their best approach to meet the compliance date. Regardless of the GUDID submission method chosen, there is a cost to compliance. Many labelers, especially those with a large number of device records, have found that submitting in HL7 SPL format via the Electronic Submissions Gateway is the most accurate way to quickly meet the UDI submission mandate and maintain up-to-date records going forward.
If you need help understanding the FDA’s UDI requirements for rigid gas permeable lenses or any other device type, contact the Life Sciences Team at Reed Tech. We can help you get on the path to compliance.