For years, the de novo pathway for device approvals has been seldom used as it was a traditionally cumbersome and lengthy process. Today, however, the de novo pathway has become the fastest growing pathway to market for medical devices in the US and has the potential to become as commonly used as the 510(k). While all areas of medical device technology can benefit from this path, 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 510(k). Furthermore, the de novo can provide a competitive advantage as a barrier to entry for your competition.
Join our interactive online training course where you will learn:
- Regulatory changes that will speed your products toward approval – and how to implement them
- How do I design my de novo submission to maximize my probability of success?
- How to use the de novo as a competitive regulatory strategy to create a barrier to entry for your competition
- When and why: Is de novo the answer for you?
What to know more about the de novo? See:
Secrets of the De Novo (I): Why Aren’t More Device Makers Using It? (MedDeviceOnline, 2/5/14) available here.
Secrets of the De Novo (II): Is De Novo Right For Your Device? (MedDeviceOnline, 2/18/14) available here.