WASHINGTON—The deadline for medical device manufacturers to comply with new U.S. Food and Drug Administration identification rules is coming, but a lot remains up in the air.
FDA's Unique Device Identification system is a two-pronged approach, requiring both a bar code for machine scanning and text that can be read by the eye on most medical devices. It's an effort to manage materials better and improve the quality and safety of medical devices coming to and already on the market.
Unfortunately for manufacturers, coming into compliance with the new regulation involves much more than slapping on a new label, and time is of the essence. FDA issued the final UDI rule in late September 2013, and the first compliance deadline, for Class III medical devices and their labels and packaging, is Sept. 24. One year after that, devices described in the FDA Safety and Innovation Act as “implantable, life-saving, and life sustaining,” which are mostly class II devices, have until September 2015. The remaining Class II devices have until 2016 and by 2018, all non-exempt class I devices must also be UDI compliant, according to FDA timelines.
There is a little leeway available if a manufacturer isn't able to make FDA's UDI deadline, but it comes with a deadline of its own, the agency says.
“A labeler may submit a request for a one-year extension of the compliance dates for a class III medical device or a device licensed under the Public Health Service Act,” said FDA spokesperson Jennifer Rodriguez. “Such a request must be submitted no later than June 23, 2014. Requests for such extensions can be submitted to the FDA UDI Help Desk here.
A lengthy process
If the compliance schedule weren't complicated enough, the process itself is not simple. First, one of three accredited issuing agencies—GS1 in Lawrenceville, N.J.; Health Industry Business Communications Council in Phoenix or ICCBBA in San Bernardino, Calif. — must produce device identification codes. Next, the medical device manufacturers' working groups must identify a database to store device and product data and assign unique codes to all applicable items. From there, the manufacturer is responsible for labeling both the device and its packaging with the machine and human-readable alphanumeric codes, including direct part marking, when applicable.
“The proposed UDI rule would have required an implantable device required to bear a UDI on its label to also bear a permanent marking providing the UDI. This provision has been removed in the final rule; an implantable device will not be required to be directly marked with a UDI,” Rodriguez said. “The proposed rule also would have required a device required to bear a UDI on its label to also bear a permanent marking providing the UDI if the device is intended for more than one use and must be sterilized before each use. The final rule changes this provision to apply to devices that are ‘reprocessed' before each use; this broadens the scope of the provision.”
For most products, the DPM deadline is two years after its initial compliance date, she said.
And it's not a one-time thing. Creating sustainable in-house UDI assignment processes now is important because if a company develops a new device, significantly enhances an old one or acquires new products through mergers and acquisition, FDA says each product will all need a UDI.
For some companies, especially those with many versions of one device or even thousands of different devices, adapting to the new government regulations could be daunting.
But help is available. FDA has put together a comprehensive website to provide guidance on the GIUDI and UDI rules and a list of resources.
Live seminars and webinars are popping up around the country as the countdown to the first deadline continues, many featuring Jay Crowley, vice president of the Unique Device Identification Practice at USDM Life Sciences, a global regulatory consulting firm. Before joining USDM, Crowley helped write the UDI rule while serving as a Senior Advisor for Patient Safety at FDA.
Once a number is developed and assigned, all UDI information must be submitted to FDA's Global UDI Database prior to manufacturing, the agency said. According to regulations, Class I medical devices' UDIs must include the expiration date and/or manufacturing date. UDIs for Class II devices must include lot and batch numbers. Class III device UDIs will need to include batch/lot numbers or a serial number in the UDI. While lower-risk Class I devices can include more information than necessary, high-risk Class III devices cannot include less than is required, according to FDA.