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).
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?
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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Vascular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. For more information, please visit their website by clicking here.