Regulatory body (FDA in the US) classification of your product based on products or services that work in similar ways.

The classification of your solution will impact the regulatory pathway that your solution must follow – which will have a tremendous impact on the development cost and time it takes to reach patients. Understanding your solution’s classification is needed to determine the FDA and international pathway that will be applied.

Find as many products or services as possible that operate in similar ways to your solution. Focus on products that have the same intended use and the same technological characteristics as your product. To narrow the range of classification options and submission types for the envisioned solution. Remember that competing products may operate very differently, so are not always appropriate. Collect the following information for each of the comparable solutions you find: device classification name, regulation number (7 digits), classification product code class number, submission type, physician review panel. Even if your solution is quite novel, it may be possible to classify components or utilize similar solutions as a guide. If the above methods do not result in a classification, use the CDRH Super Search. When performing a search, use the manufacturer, brand name, or common name for one or more similar products.