DIA 48th Annual Meeting
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Where is the 510(k) Today
Track
:
Track 09: Medical Diagnostics and Devices
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):
Barry Sall, PAREXEL Consulting, United States Mark Leahey, Medical Device Manufacturers Association (MDMA), United States
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.
Learning Objectives:
Describe the current status of the different 510(k) initiatives
Discuss the 510(k) program in relation to the FDA.
This session is a part of:
Handout Online
