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Enhanced Collaborative Strategies: FDA and Device Makers Focusing on Improved Device Clearance Processes
Session Chair(s)
Amnon Talmor
Senior Regulatory Specialist, Global Medical Device and Compliance Lead
Premier Research Group Ltd., United States
This session explores device industry events that have led to increased FDA involvement with device makers in order to establish mechanisms implemented since 2009 for improved product review and market clearance.
Learning Objective : Identify measures implemented to improve time to clearance/approval; Implement best practices for FDA submissions; Discuss mechanisms for communicating with FDA prior to submission; Identify resources that can provide additional information to the device clearance process.
Speaker(s)
Medical Device Updates
Roshana Ahmed, MA, RAC
MAPI, Canada
Senior Manager, Regulatory Affairs, Medical Devices
Regulatory Reviewer Perspective
Geeta Pamidimukkala, MS
FDA, United States
Biomedical Engineer, CDRH
Human Factors for Combination Products
Molly Follette Story, PhD, MS
Sanofi , United States
Senior Advisor, Medical Device Development Unit
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