Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?

So you’ve determined the classification of your medical device or in vitro diagnostic and now it’s time to select a regulatory pathway to market. Pretty straightforward decision, right? If your technology is basically the same as an existing device, you choose 510k. If not, then PMA. End of discussion, right?

Not necessarily. Sure, you can follow in the footsteps of the many device makers who have gone before you. Or better yet, you can evaluate all the potential options available and select the path that gives your product the best chance to succeed in an increasingly competitive and challenging market.

In this workshop, we will explore all pathways to market — including the little-known and little-used ones — and discuss how to decide which to use when.

Watch the webinar

MDrues webinar - 4-2-20
Using the case study approach, we’ll address these questions and more in an interactive fashion:
  • What are all the pathways to market and the advantages and disadvantages of each?
  • How do I decide which one to use and when?
  • If my device is class III, is the PMA my only option?  If my device is class II, is the 510k my only option?
  • How does the Breakthrough Devices Program (BDP) and Safer Technologies Program (STeP) affect pathway options?
  • Can I market a device without any FDA oversight whatsoever?
  • If someone else brought a similar device to market using one pathway, must I use the same pathway?
  • Must I choose only one pathway? Can I use multiple pathways for the same device at the same time?
  • How can I use label expansions to bring my device to market with less time, money and risk?
  • How can I get my device on to the market and make it more difficult for my competitors at the same time?
  • How do I integrate regulatory strategy with reimbursement strategy, product liability strategy, IP strategy, etc.?

Bottom line: not only are there multiple pathways to market but there advantages and disadvantages to each pathway one.  You can combine them, mix and match them, do very interesting things with them… All examples of competitive regulatory strategy. 

So, unless you understand all of the different possible pathways to market for your device — not just the most common ones – and the advantages and disadvantages to each, how can you decide when to use or not use each one? There are many more possibilities than most people think and learning how best to use them is creative regulatory strategy!

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
Register Now  

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.

Featured In