De Novo Classification
What is de novo classification?
De novo classification is a risk-based classification process in which medical devices are classified as Class I or II based on the level of controls needed to reasonably ensure the device’s safety and efficacy.
Previously, any new device was immediately classified as a class III device after the FDA determined the device had no substantial equivalent while reviewing its 510(k) application. With a 2012 amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act, manufacturers of low- to moderate-risk devices can apply for a de novo classification without submitting a 510(k).
The de novo classification is appropriate for devices that have not been classified under section 513(a)(1) of the FD&C Act, meaning the device does not fit into a particular class, is not equivalent to any device currently marketed, and has not been determined to be substantially equivalent because of a 510(k) application.
The de novo classification is only for low- to moderate-risk devices that meet all the requirements for class I or II classification.
How does the de novo classification aid medical device approval?
The de novo classification offers a pathway for seeking FDA approval on medical devices unlike any medical device currently on the market. It is a method of classifying the device based on its risk level, which then aids regulatory control regarding the device’s requirements for market approval.