The “New” 510(k): How Do You Show Substantial Equivalence without Using a Predicate? 

This on-demand webinar hosted by Greenlight Guru focuses on the Safety and Performance Based Pathway (sp510k) as a new approach within the 510(k) premarket notification process.
This session is crucial for medical device professionals seeking to understand this alternative pathway for demonstrating substantial equivalence without using a predicate.
Main points covered:
1. Introduction to the Safety and Performance Based 510(k) and its purpose.
2. Comparison between sp510k and other 510(k) types.
3. Strategies to demonstrate substantial equivalence under sp510k.
4. Pros and cons of using the sp510k pathway.
5. Eligibility criteria and future outlook of sp510k.
Target Audience:
• Medical Device Executives
• Regulatory Affairs Professionals
• Quality Management Professionals
• Clinical Affairs Professionals
• R&D Engineers
Access the printable slides for this presentation here:
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