The De Novo request/classification is a path for the US Food and Drug Administration (FDA) to classify novel medical devices, in case the applicant cannot find a legally marketed predicate device. In general, US FDA will evaluate safety and effectiveness for the intended use of the novel medical devices, to give reasonable assurance of the user's rights [1].

According to the original FDA Modernization Act of 1997 (FDAMA), novel medical devices are automatically placed in Class III, if the device receives a "not substantially equivalent (NSE)" determination from FDA.

However, FDA’s Safety and Innovation Act 2012 (FDASIA) allows De Novo classification requests to FDA without first submitting a 510(k). Also, if the novel devices belong to the low to moderate risk products, there are two choices for De Novo classification:

  1. 1. When the applicant receives an NSE determination in response to a 510(k) submission, the applicant can directly submit a De Novo request for the medical device within 30 days of the receipt of the NSE determination. FDA will then make a risk-based evaluation for classification of the device into Class I or Class II.
  2. 2. Directly submit a De Novo request to the FDA without first submitting a 510(k), if there is no legally marketed device to base a determination of substantial equivalence.

The applicant may submit the De Novo request to FDA again when FDA gives NSE determination. The applicant can further modify and submit the registration application to FDA within the FDA time limit to save time [2].

FDA intends to utilize the De Novo process for increasing the existing 510(k) database of predicate products and to modifying/increasing the current classification system. In this way, FDA can facilitate and improve future 510(k) submissions [3].




  1. 1. De Novo Classification Request
  2. 2. Evaluation of Automatic Class III Designation (De Novo) Summaries
  3. 3. Medical Device De Novo Classification Process