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Advanced Strategies And Tactics For Using The De Novo Pathway

There are many pathways medical device manufacturers may use to bring devices to market. Some, like the 510K and PMA, are commonly used while others like the de novo are not.

Although the de novo has not been frequently used in the past, recent changes in regulation including FDA's new “final” guidance that was released on Oct 30th, 2017, "De Novo Classification Process: Evaluation of Automatic Class III Designation" have made this pathway more attractive to many device manufacturers for the future.

While all areas of medical device technology may benefit, the de novo is particularly attractive in the areas of mobile medical apps, imaging and in vitro/companion diagnostics.

In many ways, the de novo is the simplest pathway to market, even simpler than the 510k!

Taken further, the de novo may be used as a competitive regulatory strategy not only to bring a device to market but also to create a barrier to entry to the competition!