During my work experience, if we need to file for 510k or FDA approval, we use the flowchart developed by the company and the FDA to guide us during the entire process. The process is so broad that there are multiple steps and different classification of device before submitting an application for an approval. At many times, if it’s a family of parts or a component of a previously approved device, we refer to the old application filed for guidance. Lastly, it can be a challenge differentiating medical devices into its classes, but it’s very important for a company classify accurately.