The De Novo process is one that has not been widely used by most of the medical device industry. In 2020 there were 26 de novo requests issued, compared with over 500 (search limit) 510(k)s and PMAs. If a person believes their device is appropriate for classification into Class I or Class II and determines, based on currently available information, there is no legally marketed predicate device, they may submit a De Novo request so that the FDA might classify the new device.
On October 5th, 2021, the FDA released four final guidance documents related to the De Novo process:
- Acceptance Review for De Novo Classification Requests
- De Novo Classification Process (Evaluation of Automatic Class III Designation)
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
- User Fees and Refunds for De Novo Classification Requests
At Empirical, we submit up to 50 510(k)s in a year, and many of those are for devices that are “pushing the envelope” when compared to predicate devices. These submissions for devices with technological features that vary greatly from the other devices on the market can be some of the most difficult. With the FDA’s new focus on improving the de novo system, we will be looking at using this process more often in the future. Small companies, which generally have the most innovative products, should consider utilizing this process within the FDA instead of trying to design “me too” into their creative products. This is a way the FDA is working to allow more device to gain clearance, especially when combined with programs like the Breakthrough Device Designation.