Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate you have designed and developed a medical device that meets user needs, is safe and effective.

The relationship between Design Controls and regulatory submissions is strong. Design Controls are needed to ensure that you have the data to support your submission to the FDA for pre-market notification. A traditional FDA 510(k) submission contains 20 sections, and many of those sections are linked directly to Design Controls.