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).

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