Medical devices do not have subclass codes and are represented by a hyphen. The subclass should specify the primary material which contacts and/or holds the product. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Class is more specific than an industry code for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products.Ĭlass Code: This element is always one letter (a-z) and is directly related to an industry. Industry Code: This element is two numbers from '02' to '98.” An industry code determines the broadest area into which a product falls. The string of letters and numbers represents five components: Industry Code, Class, Subclass, Process Indicator Code (PIC), and the Product (Group). Visit the Product Code Builder Application and Tutorial for more information on building product codes.

The easiest way to determine the product code is to become familiar with the product itself, including the label, the processing information, intended use of product, the container type, who will use or consume the product, etc. If the product has more than one name (e.g., a fish known under several regional names), the product code may have several different synonymous definitions associated with it.

The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product. What resources are available to help me create a product code?Īn FDA product code describes a specific product and contains a combination of five to seven numbers and letters. What is the structure of an FDA product code?

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