Now that the comment period for FDA’s proposed unique device identification (UDI) rule is closed, many manufacturers are in a holding pattern, waiting to see what FDA will include in the final rule, which could be out as early as this June. But if you talk to industry experts, now is the time for orthopaedic OEMs to get busy, as they will be among the first to be impacted by the regulation. FDA, meanwhile, is hard at work sorting through hundreds of comments submitted on the proposed rule. Those comments address myriad topics, from the compliance timeline to requirements for direct part marking of implantable devices. But when it is all said, read and done, the biggest challenges for manufacturers are bound to be all about the data.
First, here’s a little background on UDI. The proposed rule, which was published in the Federal Register in July 2012, is the result of language included in the FDA Amendment Acts of 2007, requiring medical device labels to bear a unique identifier that “shall adequately identify the device through distribution and use, and may include information on the lot or serial number.” However, as with any regulation, it’s more complicated than that. In addition to assigning a code that is part of the ISO 15459 series of standards to each of their products, OEMs must make sure the label displays the code in both human- and machine-readable formats. However, the highest regulatory hurdle appears to be the requirement to populate an FDA Global UDI Database (GUDID) with specified data about those products. While the data elements that OEMs need to submit to the GUDID have likely been included in one regulatory filing or another, they are owned and managed by different business functions that have historically not worked closely together.
Locating, harvesting and aggregating the data can be quite challenging, says Mike Gillespie of GHX Business Solutions, who advises manufacturers on how to prepare for UDI. The data elements exist in a variety of places and formats, some not even electronic. It’s even harder for suppliers that have gone through mergers and acquisitions, Gillespie adds. One division might keep a certain attribute in an ERP system, while another division might keep the same attribute in an entirely different place.
While not final, FDA has listed these attributes to date for inclusion in the Global UDI database.
• Issuing Agency
Developing a sustainable process for publishing data to the GUDID requires a cross functional business process involving a wide variety of stakeholders, including but not limited to:
- Process engineering
- Supply chain
- Labeling and barcoding
- Information technology
- Marketing and sales
Getting all of these players together is an exercise in change management, but it is absolutely critical to manage highly-dynamic data. Gillespie says on average 30 percent of products sold in the U.S. have some kind of change in their associated data elements each year. As many of the manufacturers pointed out in their comments, FDA is not expected to fully define the required attributes until the final rule is issued, and unless things change, manufacturers of Class III orthopaedic devices would only have one year to prepare to populate the GUDID.
Overall, the comments received came from a wide range of organizations, including suppliers, healthcare delivery organizations and physicians. In general and not surprisingly, suppliers asked for delays in timelines and more product exemptions, while hospital groups called for faster timelines and fewer exemptions.