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!
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
About the presenter:
Michael Drues, Ph.D., is President of Vascular Sciences, a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools onground & on-line.
