The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?

Everyone knows there are three types of Premarket Notifications a.k.a. 510(k)s – traditional, special and abbreviated – or are there?

The “new” Safety and Performance Based Pathway” is an expansion of the abbreviated 510(k) for certain “well understood” devices.

In this free in-depth webinar, presented by world-renowned regulatory expert Michael Drues, Ph.D., we will explore what some call the “new” safety and performance based 510k (sp510k).

Watch the webinar

M.Drues webinar 11-4-21
Specifically, this webinar will cover:
  • What is the sp510k and why was it created?
  • How is the sp510k similar and different to other types of 510k’s?
  • How do you show substantial equivalence without using a predicate?
  • What are the advantages and disadvantages of using the sp510k?
  • What types of devices are eligible for the sp510k?
  • What is the future of the sp510k? Will it gain popularity?
Simply put: if you’re working in the medical device world and you don’t know all your options to bring your device to market and the advantages and disadvantages of each – including the sp510k – how can you do your job?
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.

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