Survey: Most Devicemakers Not Ready for Looming UDI Regs
Only about 15 percent of device manufacturers of Class II and Class III devices are currently compliant with new unique device identifier requirements that go into effect Sept. 24, according to a recent survey.
Roughly half of the 120 medical device companies polled hadn’t even conducted internal audits, and 53 percent said they would need additional support for their UDI processes to meet the regulatory requirements.
The survey showed that 93 percent reported that UDI requirements have had a major or at least noticeable impact on their existing labeling processes.
Only half of respondents felt that their current barcode labeling software solution would be able to scale to meet long-term UDI regulations and other evolving international requirements, according to the survey conducted by Loftware and USDM Life Sciences.
“Despite adequate lead time, just 15 percent of respondents indicate that they are already compliant with the next phase of the regulation, and of those who are currently working towards compliance, nearly 40 percent will be taking it right to the due date of Sept. 24,” the report said. “For regulations that they’ve been aware of for three years now, it’s surprising that so many companies are cutting it this close with impending deadlines.”
Top Challenges
Devicemakers said that getting all of the necessary data on the label is one of their top challenges (50 percent) as well as pulling labeling data from enterprise applications (45 percent). About 36 percent of companies said understanding and applying the regulation was also a challenge (see chart below).
The FDA issued draft guidance in July that clarified agency expectations for UDIs, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form (IDDM, July 29).
UDI labeling regulations are being phased in through 2020 in a concerted effort to identify and track medical devices. The Sept. 24 deadline requires labels and packages of Class II devices to bear UDI barcode labels with correctly formatted dates, and the data must also be submitted to FDA’s Global Unique Device Identification Database (GUDID). Class III devices that are intended for reuse must also bear a UDI as a permanent marking on the device itself.
“Many device manufacturers are struggling to meet the FDA UDI compliance timelines – however, the overriding issue to UDI compliance is in developing and implementing a sustainable, extendable UDI program and understanding that UDI is and will be a constantly growing and evolving process,” the report says.
The FDA likely saw the writing on the wall that devicemakers would need more time to comply, because it released a notice on Aug. 19 reminding manufacturers that they could apply for extensions. The notice also listed exemptions for certain devices as well as the process to request an exemption or extension.
In addition, the agency provided advice for labelers struggling with fitting all the information on the label. It said that labelers could:
- Remove or minimize information on the label that is not required under 21 CFR 801 (or 21 CFR 809.10 for IVDs);
- Increase the size of the label or modify the label, such as moving the label to a flatter location on the immediate container to accommodate the UDI; or
- Use a smaller form of AIDC technology or split the AIDC form into multiple segments. The easily readable plain-text UDI may also be split into multiple segments.
The agency noted that if those solutions don’t address labelers’ concerns, the company could submit a request for an alternative to add an overwrap that would bear the UDI or place another label bearing the UDI elsewhere on the packaging.
Read the FDA notice here: www.fdanews.com/08-24-16-UDIexceptions.pdf and the industry survey here: www.fdanews.com/08-24-16-UDIsurvey.pdf. — Tamra Sami
