What does a De Novo application allow for?

The De Novo application is specifically designed to streamline the regulatory pathway for novel medical devices that are classified as Class III due to their inherent characteristics or risk profiles, yet do not have a predicate device. This application allows for the reclassification of these devices into Class II (or in some cases Class I) if the FDA determines that the general controls, along with any special controls determined appropriate during the De Novo process, are sufficient to provide a reasonable assurance of safety and effectiveness.

This means that if a device is considered too novel to have a direct predicate and is initially placed in Class III, the De Novo pathway allows for a more efficient regulatory route to bring such devices to market while also reassessing their classification based on the device's risk profile and intended use. This flexibility supports innovation while ensuring safety and effectiveness for patients.

The other options do not accurately describe the De Novo process:

• Approval of entirely new devices with novel technology does partially relate to De Novo applications, but it is specifically the reclassification aspect that is central.

• 510(k) clearance is unrelated to the De Novo process, as it pertains to devices deemed substantially equivalent to a predicate device.

• Marketing of devices that were previously deemed misbranded does not involve De Novo; instead,