FREE ON-DEMAND WEBINAR
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
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?
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
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