Journal of Pharmacovigilance

Understanding the US medical device premarket notification review process

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Heather Rosecrans

Greenleaf Health, USA

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Approximately 95% of medical devices in the USA today are marketed under the Premarket Notification 510(k) requirements of the US Food, Drug, and Cosmetic Act. This session will provide the latest developments in the 510(k) review process with helpful tips on corresponding optimal regulatory strategy, when and how to contact the US Food and Drug Administration, and how to optimize opportunities for a predictable 510(k) review experience. The session will focus on a robust baseline in the fundamentals of 510(k) submissions, from underlying regulations to unique regulatory concepts, and finally the practical aspects of preparing a 510(k). There will also be discussion on post-market requirements such as registration and listing, device modifications, marketing and promotion in the USA

Biography :

Email: Heather.rosecrans@greenleafhealth.com