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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
Senior Manager, Regulatory Affairs, Medical Devices, MAPI, Canada
Regulatory Reviewer Perspective
Geeta Pamidimukkala, MS
Biomedical Engineer, CDRH, FDA, United States
Human Factors for Combination Products
Molly Follette Story, PhD, MS
Senior Advisor, Medical Device Development Unit, Sanofi , United States
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