Live Webinar
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510(k) Submissions: Requirements, Challenges and Successful Clearance
Date & Time: Thursday, April 19, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: David Nettleton
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Why should you attend:
David Lim Chairman and CEO, Regulatory Doctor
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What is 510(k)? What is a 510(k) submission? What are the applicable federal statutes and implementing regulations for 510(k) submissions? How the medical devices are classified? What are the challenges and hurdles during the 510(k) preparation, submission, and review process? How to identify applicable regulatory requirements? How to demonstrate applicable regulatory requirements (e.g., performance requirements including clinical studies, if applicable)? What are the common deficiencies in 510(k) submissions? How to format a 510(k) submission using the CAC-SI method?
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FDA regulations applicable to a 510(k) submission
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510(k) program and recent changes in the 510(k) program 510(k) regulatory requirements 510(k) submission requirements for medical devices and in vitro diagnostic devices
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List of applicable FDA guidance documents List of applicable reference standards Systematic methods to increase 510(k) submission quality.
Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. ...more
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Formatting a 510(k) for submission 510(k) submission template for medical devices. 510(k) submission template for in vitro diagnostic devices. Instructor's unique practical and actionable strategy CAC-SI method
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Regulatory Affairs
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Quality Associates Compliance Specialists Research and Development (R&D) Managers
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Product and Development (P&D) Managers Risk Management
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