There are many reasons the FDA’s De Novo applications grow monthly. Simply put, the more innovation in the medical field, the more distinct new medical devices become compared to what has come before. And “more distinct” means “no obvious predicate device” more often than not. As such, two options exist for unique devices with no predicates, or NSE (not substantially equivalent): 1) become an automatic Class III device or 2) try the DeNovo path. It’s clear which option most are choosing.
First and foremost, the De Novo option acts as a mechanism to get novel devices approved by the FDA by avoiding an automatic Class III designation. If your company’s unique medical device has no predicate device, the De Novo designation offers a pathway to success. Let’s review a history of the process and when to choose this approach to clearance.
A Peak into the De Novo History File
The De Novo pathway has been around for over two decades. However, most medical device companies rarely use it. Even though De Novo applications grow, most companies decide to take the traditional 510(k) pathway instead. Though both pathways are possible for Class I and Class II devices, many companies are unfamiliar with the current De Novo process.
The FDA introduced De Novo in 1997 with a 510(k) submission requirement. Then in 2011, requirement of a 510(k) submission dropped. In brief, the key difference between the 510(k) submission and the De Novo submission is the device itself.
What’s the Difference?
510(k) submissions rely upon a predicate device demonstrated to be substantially equivalent for market clearance. However, De Novo submissions don’t use any existing equivalence factors as a basis for the approval of the device. As such, if your Class I or Class II device does NOT have a substantially equivalent device already on the market, offers low to medium risk to users, then the De Novo classification pathway provides a good alternative.
Creating a completely novel device is a challenge. On the other hand, it also means your device is completely new and unique without a simple, traditional path for FDA clearance. Recent approved devices under the De Novo option include a wide range of innovative solutions to reduce pain, diagnose disorders, and improve the lives of many.
Contact MAE Group to get help in determining which path, De Novo or other, is best for your device. Having the right expertise and experience on your side will ensure your path to market is smooth–saving you time and money.