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Program Code:
138
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Heather Rosecrans, Greenleaf Health LLC, United States
PRESENTER
(S):
Mr. Sall is a Principal Consultant with PAREXEL Consulting in Waltham, MA. His areas of responsibility include strategic regulatory consulting involving medical devices and combination products.
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Mark Leahey,
Medical Device Manufacturers Association (MDMA), United States
Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents hundreds of research-driven medical technology companies.
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Description
This session will discuss the 510(k) Program, post IOM 510(k) Report, and where FDA stands on the list of their action items related to the 510(k) Program.
Learning Objectives:
Describe the current status of the different 510(k) initiatives
Discuss the 510(k) program in relation to the FDA.