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!

Watch the webinar

Using the case study approach, participants will specifically learn:
      • What is the de novo pathway and when can I use it?
      • What were the recent changes in regulation and how can they be used today?
      • How do I design my de novo submission to maximize my probability of success?
      • How can I use the de novo pathway to my competitive advantage?

The webinar will also discuss all four de novo guidance documents including the two newly released:

      • New “Final” Guidance: De Novo Classification Process: Evaluation of Automatic Class III Designation (October 30, 2017) available here.
      • New “Draft” Guidance: Acceptance Review for De Novo Classification Requests (October 30, 2017) a.k.a. “The De Novo RTA Guidance” available here.

And practical tips on how to best implement them!  

Who Should Attend?
      • Medical Device Executives
      • Regulatory Affairs Professionals and Management
      • Quality Professionals and Management
      • Clinical Affairs Professionals and Management
      • R&D Engineers and Management

Hosted by

M.Drues Headshot circle (3)
Presenter: Mike Drues

President, Vascular Sciences

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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