PCB Tutorial
Lesson 3 — The Structure of the FDA Product Code
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Elements of the Product Code
The FDA Product Code is seven characters long and is broken into the following five fields.
(numeric)
(alpha or numeric)
(alpha or "-")
(alpha,numeric
or "-")
(alpha or numeric)
Industry Code is the first of five elements that comprise an FDA product code. This element is two characters in length and currently consists of numeric data. Industry codes range from "02" to "97". An Industry code determines the broadest area into which a product falls. Some examples are Dental for all dental-related medical devices and Fishery/Seafood for fish and seafood products.
Class is the second of five elements that comprise a FDA product code. This element is one character in length, and is an alpha or numeric character. This element is directly related to an Industry. This code designates the food group, source, product, use, pharmacological action, category or animal species of the product. A Class code is more specific than an Industry; for example, the Fishery/Seafood products Industry may contain Classes such as Smoked, Breaded and such. However, not all Industry codes have specific class elements. See Lesson 7 — Coding Medical Device, In-Vitro Diagnostic, and Non-Medical Radiation Emitting Products for more information.
Subclass is the third of five elements that make up a FDA Product code. This element is one character in length, and is always an alpha character or a hyphen "-". It represents the container type, method of application, use, market class, or type of product. The Subclass relates directly to a particular Industry grouping and utilizes a unique set of definitions specific to those products. At this time, it is not used in medical device product codes and some animal use products. When not used, subclass is represented by a hyphen "-".
Process Indicator Code (PIC) is the fourth of the five elements in the product code. This element is one character in length and is always an alpha, numeric or a "-". It specifies either the process, storage or dosage form depending on the type of product. In the case of kitchenware, the PIC describes the material that the product is made of. At this time, it is not used in coding some products such as cosmetics, medical device product codes and some animal use products. The PIC code is represented by a hyphen "-" for those Industries to which it does not apply.
Product is the fifth and last element that comprises the product code. This element is two characters in length and may contain either numeric or alpha data. The Product relates directly to a particular Industry/Class combination. For example, for the Fishery/Seafood Industry and the Smoked Class within that Industry, specific types of seafood (sole, flounder, salmon, etc.) would have specific Product element values.
For medical devices, the Product element is two alpha characters. While it has no particular meaning, used in conjunction with the Class element it identifies a specific product. See Lesson 7 — Coding Medical Device, In-Vitro Diagnostic, and Non-Medical Radiation Emitting Products for more information.
The Product Code Hierarchy
For most products, the five components are hierarchically related, as indicated by the following diagram:
-
Industry Code
-
Class
- Product
- Subclass
- PIC
-
Class
The Industry Code must first be determined before the Class, Subclass, or PIC can be determined; and the Class must be determined before the specific Product code can be determined. You can streamline this process when you use the Product Code Builder Application. Use Option 3 Search Product Name to search for the product name or a keyword associated with the product name. The search results will be categorized by Industry. Select a product in one of the industries and the application will select the corresponding Class code. Then determine the Subclass and Process Indicator Code to complete the Product Code.
Check Your Knowledge
Case Study — Putting it all Together
The case study walks through the coding process step-by-step. Read through the case study and answer the questions.
Let's say you need the product code for cans of Condensed Cream of Mushroom Soup. The first step is to determine the Industry Code. Searching the list of industries, you will come across an industry labeled Soups. The Industry Code for Soups is 38.
The next step is to select the Class code. Under Industry Code 38- Soups there are thirteen Classes. Which class best describes the product you are coding? (Click on your choice)
Now you select the Subclass. Remember it is dependent on the Industry and Class selected. In this case, there are thirteen possible Subclasses for Soup, Creamed. (Click on your choice)
The last step is to select a Process Indicator Code or PIC. Again, the PIC depends on the Industry and Class previously selected. Within food industries the PIC refers to processing info.(Click on your choice)
The Product Code Builder Application is set up to select the Product next. Then you select the Subclass and PIC codes. In our example, there are 26 products listed including Number 19 — Mushroom, Creamed, Concentrated. That is the one you would select. The Product so far looks like this:
Soups
Soup, Creamed, Concentrates
Mushroom, Creamed, Concentrated
Here's what the final product code for cans of Condensed Cream of Mushroom Soup looks like:
Product: Condensed Cream of Mushroom Soup
FDA Product Code:
Soups
Soup, Creamed, Concentrates
Metal (cans, etc.)
Commercially Sterile
Mushroom, Creamed, Concentrated