Improving 510(k) Submission Quality

Duration: 60 Minutes
This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)”) is made to US FDA.
510 (k) submission
Instructor: David Lim
Product ID: 500030
The 510(k) is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is to demonstrate that the subject device (to be marketed or new device) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). During the 510(k) preparation, improving 510(k) submission quality can save significant amount of your business time, money, and resources by avoiding encountering lots of hurdles during the review process in a predictable and foreseeable manner.

To bring a product to market fast through the 510(k) program, it is imperative the medical device manufacturers understand the 510(k) processes with awareness of potential hurdles and be able to prepare 510(k)s in a way to proactively expedite the review process for timely clearance, potentially saving millions of dollars to the businesses. This 60-min webinar will greatly help you improve your 510(k) submission quality, inspiring you to take or choose to take different approaches when preparing your next 510(k)s.

Objectives of the Presentation:
  • Statute(s) and regulations for 510(k)s
  • Definitions
  • Regulatory provisions, device classification, and product codes
  • What actions require 510(k)s (traditional, special, or abbreviated)
  • Who is subject to 510(k) submission
  • How to identify a suitable predicate device(s), if any
  • How to demonstrate substantial equivalence
  • 510(k) program, processes, and decision points during 510(k) review
  • Differences in contents of 510(k)s based on products
  • Quality submission requirements
  • How to identify and address regulatory requirements and safety issues
  • Data summary and presentation
  • How to identify potential risks and establish risk criteria
  • Communication, interaction and negotiation with the FDA reviewers
  • Speaker’s methods, tools, strategies, and much more.
Who can Benefit:
  • Regulatory Affairs Managers, Directors and VPs
  • Clinical Affairs Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Quality Managers, Directors and VPs
  • Compliance Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Complaint Handling and Risk Management Managers and Directors
  • Site Managers, Directors, and Consultants
  • Senior and Executive Management
  • Compliance Officers and Legal Counsel
  • Business Development Managers, Directors, and VPs
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

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, Caltech, 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), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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