Washington, DC, which is anything but a bastion of certainty around healthcare these days, handed medical device manufacturers a bit more clarity last week around the timeline for the unique device identification (UDI) rule. Congressional negotiators retained language in the reconciled FDA user fee act that would require publication of the proposed rule by the end of the year. The bill also requires the final rule to be published within 6 months after the close of the comment period on the proposed regulation and, more importantly, for “devices that are implantable, life-saving and life-sustaining” to bear the unique identifiers no later than two years after the regulation is finalized.
This time the language looks like it will make it into law. Legislators on both sides of the political aisle – another rarity these days – are fast tracking the bill in hopes of having it ready for signature by the end of the month and out of the fray of the U.S. Supreme Court ruling on the Affordable Care Act, which is also expected by month’s end. The house passed the user fee act last Thursday, and the Senate is expected to follow suit this week.
This will (or should) serve as a wake-up call for medical device manufacturers that the regulation is coming and provide a timeline that they can plan around. The FDA has previously estimated the comment period to be 90 days and the regulation to go into effect for Class III devices (which includes implantables) 12 months after the final rule is published. While these timelines are subject to change, I am still amazed at the lack of widespread awareness of the pending regulation among many manufacturer representatives, especially given that language calling for creation of a UDI system was included in the FDA Amendment Acts of 2007. Earlier this month, I spoke at a conference for orthopedic device manufacturers and asked those in the audience –from manufacturers large and small – who had heard of UDI. Only one person raised his hand.
Next week, I will begin a multi-part series on what suppliers and providers can do now to get ready for UDI. Implantable device manufacturers will be the first to be impacted, and those that have extensive product lines and manufacturing sites around the world will have the most to do. But some suppliers that are not be among the first to be impacted by the regulation have started getting ready for UDI, sooner rather than later, in part to meet growing customer and regulatory demands to use the GS1 Global Trade Item Number (GTIN), which is one although not the only standard that will suffice for UDI. Siemens Healthcare Diagnostics documented how and why it decided to take action now in a case study. While the FDA only has jurisdiction over suppliers, providers may also want to consider how they will capture and use the identifiers in the future. There are benefits that can be realized through voluntary adoption (from recall management to clinical documentation of products used in patient care), but there is talk in Washington, DC of requiring usage of the unique identifiers by providers in the future. We’ll talk more about that next week. For now, it’s up to the Senate to make the next move.