In an effort to avoid any major interruptions in device access, FDA has finalized guidance that will give device manufacturers more time to take legacy FDA identification numbers off of certain device labels.
Device makers have three more years to meet a particular requirement of the Unique Device Identifier (UDI) rule. FDA has issued final guidance that extends the deadline for removing legacy FDA identification numbers from device labels and packages from September 24, 2018 to September 24, 2021.
In its August 30 final guidance document, FDA explained that potentially reimbursable devices that are sold through a pharmacy usually have a reimbursement number like a National Health Related Item Code (NHRIC) or National Drug Code (NDC) on their label. The UDI rule requires that legacy identifiers be removed once a device is required to have a UDI—or, if the device isn't required to have a UDI on its label, the legacy number is supposed to be removed by September 24, 2018. This was originally intended to reduce potential confusion, FDA wrote.
Get your fill of product development inspiration at the MD&M Minneapolis Conference, September 21-22.
Now, FDA has made it clear it "does not intend to enforce the prohibition against providing NHRIC and NDC numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021."
The agency's about-face was spurred by stakeholders' concerns that the original timeline could possibly lead to reimbursement, supply chain, and procurement interruptions. FDA wrote in this week's guidance document, "We therefore recognize that additional time is appropriate for stakeholders to make changes to ensure that medical device reimbursement, supply chain, and procurement systems and processes will not depend on NHRIC and NDC numbers."
Despite the risk of confusion about using different types of identifiers at one time for a medical device, FDA wrote that it believes "this enforcement policy will both facilitate a consistent date by which all classes of devices have legacy NHRIC and NDC numbers removed, and make the transition away from using these legacy FDA identification numbers less disruptive and more predictable."
FDA is also allowing device makers to make requests to keep using previously assigned FDA labeler codes. Those requests can be made until September 24, 2021 as well.
[Image courtesy of GRAPHICS MOUSE/FREEDIGITALPHOTOS.NET]