Overview and Panel Discussion: Faculty
FDA Perspective and Update: Christy L. Foreman, Deputy Division Director for Div of Enforcement B, Office of Compliance, CDRH, FDA (via call in); and Heather Rosecrans, ODE, CDRH, FDA
How a Division within a Multinational Manufacturer is Preparing to Change Processes: Preeti Jain, Director, Regulatory Affairs, Cardiovascular, Medtronic
Small Company Strategies for US Regulatory Submissions: Richard Jansen, Pharm. D., President, Silver Pine Consulting, LLC, Vice President, K Spine, Inc.
Identify current issues with FDA regulatory submission processes.
List strategies and tactics for small companies pursuing US regulatory approvals.
Identify internal planning and communications tools for working in the current regulatory environment.
510(k) Reform: Impact on Preclinical Testing Requirements: Miriam C. Provost, Ph.D., Senior Consultant, Medical Devices, Biologics Consulting Group, Inc.
This presentation will discuss the impact of 510(k) reform on preclinical testing used to support substantial equivalence including the impact on bench and animal testing, comparisons to a predicate device and determining when clinical data are required.
Financial Impact: Mir Imran, Chairman & CEO, InCube Labs LLC, Managing Director, InCube Ventures
510(k) process and current requirements
Examples of recent 510(k) clearances
Trends in regulatory and clinical
Best practices and lessons learned for med tech entrepreneurs
What this means for your projects and your company: Janice Hogan
For further information please visit the MD&M Minneapolis website.