What is the purpose of the De Novo Process in FDA regulations?

The De Novo Process is designed to provide a pathway for the marketing of low to moderate risk medical devices that have previously been classified as Class III due to a lack of predicate devices. When a new device is developed and does not have an existing counterpart that is already on the market, the manufacturer may seek De Novo classification to categorize the device into Class I or Class II, meaning it can be marketed with less regulatory burden than Class III devices, which generally require more extensive testing and approval processes.

This process is significant because it allows for innovation in the medical device field by enabling manufacturers to bring low to moderate risk devices to market without the lengthy and costly requirements that are necessary for higher-risk classifications. Therefore, the correct choice reflects the intent of the De Novo pathway, which facilitates the classification and marketing of these devices, addressing the gap where no predicate devices existed, making it a vital part of the regulatory framework for medical devices.