'Legally marketed device' presentation slideshows

OIVD Workshop Premarket Notification (510(k)) April 22, 2003 Parklawn Building Rockville, MD

OIVD Workshop Premarket Notification (510(k)) April 22, 2003 Parklawn Building Rockville, MD Presented by Marjorie Shulman Premarket Notification Staff Office of Device Evaluation Center for Devices and Radiological Health (301) 594-1190 x 144. What is a 510(k)?.

663 views • 51 slides

362 views • 24 slides

510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives. Terry Sullivan Vice President, Regulatory Affairs. What I will cover today. Survey of audience Overview of 510(k) pathways Traditional Special Abbreviated Perspective on some options available to manufacturers STED

318 views • 21 slides

510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives. Terry Sullivan Vice President, Regulatory Affairs. What I will cover today. Survey of audience Overview of 510(k) pathways Traditional Special Abbreviated Perspective on some options available to manufacturers STED

214 views • 21 slides

510(K) Submission - A Comprehensive and an Updated Overview

Why should you attend: The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). For More Details: Email: david@grcts.com Tel: 1-248-233-2049 Web: www.grcts.com

119 views • 7 slides