Unique Device Identifier (UDI) provision implementation is proving to be a large undertaking — a project involving many dependent tasks with multiple stakeholders including supply chain, pharmacies and payers. “The UDI Rule, established in the Food and Drug Administration Amendments Act of 2007 (FDAAA), includes a provision that rescinds any NHRIC or NDC number assigned to a device.” The extension to 2021 is being allowed to avoid possible disruption that could interfere with patient access to devices. The extension was made based on feedback from industry — the guidance released on August 30th indicates that “FDA has revised the guidance to reflect the Agency’s intent not to enforce the prohibition against providing National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021. We expect the UDI labeling requirements will be fully implemented by September 24, 2021. We also believe additional time is appropriate for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems, which do not depend on having an NHRIC or NDC number on the device label.” Zachary Brennan reports additional information on this topic in his informative article on RAPS.
Need help ensuring your company’s UDI compliance? Contact Pearl Pathways to start the discussion of how we can help your team.