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Regulatory News | 03 April 2017 | By Zachary Brennan
The US Food and Drug Administration (FDA) last week granted a third extension for soft contact lens labelers yet to comply with the requirements of the Unique Device Identification (UDI) system because of the agency’s resource limitations.
In September 2013, FDA published a final rule creating a UDI system and outlining labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the US, unless an exception or alternative applies.
The rule, which is being phased in over seven years, set a compliance date for class III devices of 24 September 2014 and a deadline of 24 September 2016 for class II devices.
FDA has previously granted two extensions to the soft contact lens industry – the first in August 2014, a one-year extension for class III soft contact lens devices and the second, dated 6 October 2015, granted an additional two-year extension for class III soft contact lens devices and a one-year extension of the 24 September 2016 compliance date for class II soft contact lens devices.
The extensions granted by the second letter expire on 24 September 2017.
“We granted these extensions because 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 (DI) to each prescription, would have resulted in an exceptionally large number of virtually identical DI record submissions,” FDA explained.
“We had expected that, during the extension periods, we would develop a technical solution that would allow contact lens DI record information to be submitted in a manner that minimizes data redundancy while still allowing end users to search and retrieve device identification information pertinent to soft contact lenses (Technical Solution). Unfortunately, given resource limitations, we have been unable to develop the Technical Solution and need more time to develop an approach that ensures that meaningful data will be submitted to GUDID.”
Now, FDA says it will grant another extension of the requirements to provide a UDI on the device label and packages, format dates on the device label and submit data to the GUDID until one year after FDA:
1) develops and fully integrates the Technical Solution into the GUDID production system;
2) provides any necessary updated technical specifications to affected labelers;
3) notifies industry that the extension will expire, through emails to industry, communication via trade associations and via the UDI website.
Those granted this third extension include:
Tags: contact lens, UDI, unique device identification, GUDID