TBD: Unique Identifiers for Drugs and Medical Devices in the U.S.
Poster Presenter
Leyla Rahjou-Esfandiary
Lead CSO, Office of Compliance, CDER
FDA United States
Objectives
Describe the National Drug Code.
Describe the Unique Device Identifier.
Provide the UDI compliance dates.
Explain the changes coming to the NDC.
Method
Identifiers for both drugs and medical devices in the U.S. are going through some transition. The Unique Device Identification System final rule (UDI Rule) requires device labelers to include the UDI on device labels and packages, except where the rule provides for an exception or alternative. Drug are assigned a unique identifier called the National Drug Code (NDC). All drugs in U.S. commercial distribution are required to be listed with the Food and Drug Administration (FDA) using the NDC. In this session, the latest update on the transition for each identifier is discussed, and all the compliance dates and requirements surrounding the transition will be provided.
