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What is De Novo?

The De Novo Classification Request (De Novo Request) is a regulatory pathway for low-to-moderate-risk novel medical devices that do not have a predicate device. This pathway allows companies to bring new and innovative medical devices to market. This pathway is for devices that have a novel design or intended use and have not been classified under existing regulations.

For the De Novo Request pathway, the FDA expects the manufacturer to prove the safety and effectiveness of a medical device through the implementation of general controls alone or general and special controls. If a De Novo Request is approved by the FDA, the medical device will be classified as class I or Class II depending on the device’s risk level.

In 2021, FDA issued a final rule on the requirements for the medical device De Novo Request under the Federal Food, Drug, and Cosmetic Act (FD&C Act).