When and Why should I submit a De Novo Application for a Medical Device to the FDA?

The Food and Drug Administration Modernization Act of 1997 introduced the De Novo classification as an alternative way to classify new medical devices in Class III after being found "not substantially equivalent" (NSE) in a 510(k) submission. The Food and Drug Administration Safety and Innovation Act (FDASIA) further updated this on July 9, 2012, empowering companies to request the De Novo classification directly, without the need to first submit a 510(k).

There are two distinct pathways to secure a De Novo classification for new low to moderate-risk devices, each with its own set of conditions and benefits.

Option 1: If a company receives a Not substantially equivalent (NSE) determination from a 510(k) submission, they can submit a De Novo request within 30 days to have the FDA classify the device into Class I or II based on risk.

Option 2: If a company believes there is no existing device to compare for substantial equivalence, they can directly submit a De Novo request for the FDA to classify the device into Class I or II without first going through a 510(k) process and receiving an NSE determination.

Medical Devices classified through the De Novo process can be marketed and used as comparisons (predicate) for future 510(k) submissions, paving the way for growth and innovation in the medical device industry.

Since 2010, the FDA has published summaries of devices classified through the De Novo process. These summaries provide an objective overview of the scientific evidence used to approve the De Novo request, ensuring transparency and serving as a resource for manufacturers who may want to use these devices as a comparison in future 510(k) submissions.