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When the De Novo Pathway is the Simplest Way to Market


Mike Drues (President, Vascular Sciences)

Eric Steuben (Vice President, Operations, PROCEPT BioRobotics)

Location: 210D

Date: Thursday, February 8

Time: 10:15am - 11:45am

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

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 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.

Topics to be covered include:

  • What is the de novo pathway and when can I use it?
  • Recent changes in regulation and how can they be used today
  • Designing a de novo submission to maximize the probability of success
  • Using the de novo pathway as a competitive advantage
  • How will MDUFA 2018 affect future de novo submissions?