An Interactive Workshop on Premarket [510(k)] Notification Submissions

Course Description:

At this workshop, Dr. David Lim will walk you through to get familiar with the following subject areas.

510(k) Format and Contents

This workshop is intended to provide guidance on how to format 510(k) submissions including necessary contents to proactively facilitate the FDA review process for medical devices including in vitro diagnosticdevices.

Why Should You Attend:

Understanding regulatory requirements and submission quality of 510(k)s adequately addressing regulatory requirements will greatly facilitate the regulatory review process, leading to fast marketing clearance and saving millions of dollars to organizations!

At this workshop, you will get familiar with 510(k) submissions concerning medical devices including in vitrodiagnostic medical devices.

The following key areas will be discussed during workshop:

• Federal Statutes and Regulations Governing Medical Devices in the US
• 510(k) Format and Contents for Various Device Types Including In Vitro Diagnostic Devices

Instructor:

Dr. David 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 panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com/davidlim), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc.