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Walter E. Washington Convention Center

Jun 14, 2015 2:30 PM - Jun 18, 2015 6:45 PM

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

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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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