As discussed in the lecture, a 510k submission for a device can be used if the device is substantially equivalent to a legally marketed device. Once the project team determines to go down this regulatory pathway, the regulatory lead on the project has to take this a step further and determine what regulation number and product code category the device falls under. For example, if your device is a negative pressure wound therapy device, then you have to choose from:
product code OMP, regulation number 878.4780: powered suction pump
product code QFC, regulation number 878.4783: Negative pressure wound therapy device for reduction of wound complications
Choosing the correct product code and regulation number has implications on the predicate device you can choose as well as potential special controls associated with the regulation number. Does anyone have experience in this and how to make the determination between product codes and regulation numbers?
First, the adequate predicate of that device needs to be found which will be the first starting point to figure out the product code and regulation number for the medical device. For this, utilize the FDA database and search up other Premarket Notification 510(k) database, to find devices with similar intended uses or technological characteristics. If you can't find the predicate, consider reaching out to the FDA to get feedback on the appropriate classification and number. It is a very nuanced process but it requires a combination of regulatory knowledge, industry experience, and careful analysis of the device's characteristics.
The easiest way to make the determination between product codes and regulation numbers is to become familiar with the product itself, including aspects like the label, intended use of the product, and consumer of the product. Below are the steps in determining the five to seven character combination of a product code.
A product code is a unique combination of five to seven numbers and letters that are assigned to a specific product. Product codes can be found in shop and factories all over the world because they are super important when it comes to tracking items, counting how many are in stock, and figuring out sales. The structure of a product code consists of a string of numbers and letters that represent five components, the industry Code, class, subclass, process indicator code (PIC), and product (group). The industry code will be two numbers ranging from "02" to "98". These two numbers will determine the broadest area in which a product can fall into. The class code will always be one letter from a-z and will be directly related to the industry code except it is much more specific. Next, the subclass code will also be a single letter from a-z and will specify the container type of the product. The primary material that comes in contact and/or holds the product should be specified in the subclass. Similarly, the PIC also contains one letter from a-z and describes the process, storage or dosage form depending on the type of product. Lastly, the group code of the product will contain two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination, meaning it will identify the specific product that is being tracked.
Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions in the function of a medical device can solidify which category the medical device would fall into. With the process of determining product codes, it seems that the labeling and instructions of a medical device needs to be very particular. Mislabeling or misunderstandings could lead to large problems with a 510K. As talked about in the lecture, a 513G can be used as a request for information for guidance from the FDA on a device. If a company is unsure which product code to file a 510k even after consulting the database, a 513G would be an ideal step in the process. The benefit of this process is that the project could have confidence in committing towards a specific product code or regulation. The downside is that the process is formal, which is time consuming. Additionally, if the FDA's guidance results in an unfavorable response that alters the product category entirely from what was expected, it could break an entire project.
When determining the correct product code and regulation number, I think it's important to develop a detailed comparison. This tool helps align your device’s key attributes (such as intended use, material composition, and technological features) with those of potential predicate devices. By doing so, you can identify subtle differences that might affect classification and determine if any special controls apply. Additionally, regularly reviewing the latest FDA guidance documents and recall data can provide context on evolving regulatory interpretations. Engaging a regulatory affairs expert early in the process can offer valuable insights and help validate your classifications before submission. Leveraging cross-functional feedback from R&D, quality assurance, and clinical teams further refines your understanding of where your device fits within the regulatory landscape. I’m curious to see if anyone has used/developed a structured matrix or software tool to streamline this analysis?
@sn64 Hi sn64! I recently learned about a tool used at work to facilitate analysis regarding regulatory classification. The company one of my professors work for uses an AI-powered regulatory decision matrix for this process. The tool streamlines analysis by mapping key attributes against multiple potential product codes and historical 510k decisions. This program also uses TPLC (Total Product Life Cycle) as part of its database in order to identify trends and common pitfalls associated with specific classifications. I thought this was very interesting as this process was known to be done manually for many years before now!
