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Regulatory News | 20 August 2014 | By Alexander Gaffney, RAC
Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry.
A UDI is, as its name implies, a system of identifying each medical device using a specific system.
The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
At its core, the rule calls for devices to be marked with a UDI system composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.
The rule was originally mandated by the FDA Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).
The rule, which saw release in September 2013, calls for different classes and types of devices to be subject to UDI marking requirements at different times.
For example, some Class III (high-risk) medical devices had to adhere to the UDI rule's direct marking requirements within 90 days, or by the end of 2013. All other Class III devices had until September 2014 to comply.
Low-risk (Class I) and moderate-risk (Class II) devices were, on the other hand, generally given much more time to comply with the act's requirements. Class II devices have until September 2016 to comply, while Class I devices have until September 2018 to do the same. (See "Effective Dates" in the UDI Rule.)
FDA's rule also contains Section 21 CFR 801.55(d), which says the following:
"FDA may initiate and grant an exception or alternative if we determine that the exception or alternative is in the best interest of the public health. Any such exception or alternative will remain in effect only so long as there remains a public health need for the exception or alternative."
And in an announcement this week, FDA indicated that at least one group of devices had been granted an extension.
Class III contact lens and intraocular lens labelers, FDA said, would have until September 2015 to label their products in accordance with the UDI rule's direct marking requirements.
The reason for the delay, FDA explained, was because of the likelihood of an "extremely large number of data submissions to the Global Unique Device Identification Database (GUDID)"—a number so large that FDA implied it might be a burden upon both the industry and its database.
"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," FDA explained. "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."
Devices subject to the extension include the following products and codes:
FDA Extension Notice
Tags: UDI, Unique Device Identification, 21 CFR 801.55(d), Direct Marking, GUDID, IOLs, Contact Lenses