[header] How to get to get fda approval to market a medical device [title] Determine the classification of your medical device. [substeps] There are 3 classes: class i, ii, and iii. They are classified based on risk, with class i being the lowest and class iii being the greatest. 
You will find out what pre-marketing submission is required by fda based on classification of your device. General controls are assigned as class i either with or without exemptions.