June 15, 2023

Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time & Cost to Market

According to 2022 statistics, the average cost to obtain a 510(k) from concept to clearance is $6.1M ($200K-$41M) and the average clearance time is 33 months (2 months-11 years).

So why does it take so long and cost so much? Showing substantial equivalence or the lack thereof is without a doubt one of the biggest reasons for 510(k) delays and rejections!

The premarket notification, a.k.a. 510(k), is the most common pathway used to bring new medical devices to market in the US. Yet despite FDA issuing multiple guidances since the 510(k) was created, 75% of 510(k)s are rejected (i.e., via “additional information” requests) and of those rejections, nearly 85% are rejected specifically because of substantial equivalence or the lack thereof!

Simply put: no 510(k) should ever be rejected – and certainly not due to substantial equivalence – this is an amateur mistake! (May, 2023 MDUFA stats).

Such delays and rejections result in increases in time and cost to market – most of which could be minimized or avoided!

Bottom line: the better you understand what substantial equivalence means and how to prove it, the less time and cost of your 510(k) – it’s as simple as that… or is it?

Watch the webinar

M. Drues_GG Webinar 6-15-23
Using the case study approach, these questions and others will be presented in an interactive fashion:
  • Understand the regulatory requirements of substantial equivalence and how to use them to your advantage
  • Learn to design a substantial equivalence strategy using regulatory logic and how to defend it
  • Show substantial equivalence in all 510(k) subtypes including traditional, special, abbreviated and new safety/performance-based 510(k)
  • Appreciate the split- and multi-predicate strategies and how and when to use each
  • Learn what to do if FDA says your device is NSE, i.e., does NSE necessarily mean NSE? What are your options?
  • Discuss the proposed changes currently under debate and what the future may hold for the 510(k) program
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

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Mike Drues-1
Mike Drues

Vascular Sciences

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About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.


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 to learn more.

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