510(k): How To Navigate Through Hurdles And Get It Cleared

Duration: 60 Minutes
This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.
fda 510(k)
Instructor: David Lim
Product ID: 500021
The premarket notification [510(k)], which is made to US FDA, is the most common pathway to market for medical devices. The 510(k) premarket submission is to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). During the 510(k) processes, there could be lots of hurdles to overcome for clearance.

To expedite the process of bringing a product to market 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 quality 510(k) submissions in a way to expedite the review process and subsequent clearance.

This webinar will help you get familiar with the 510(k) processes and how to navigate through the hurdles inherent in the process. At the end of the webinar, you will leave with greatly improved awareness in that you would take or choose to take different approaches when preparing your next 510(k)s.

Objectives of the Presentation:
  • Governing Statute(s) and Regulations
  • Definitions
  • Device Classification
  • When and Who should submit 510(k)s (Traditional, Special, or Abbreviated)
  • 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
  • Common deficiencies (poor submissions) vs. quality submissions
  • How to identify and address regulatory requirements relevant and applicable to the product(s)
  • How to address potential safety issues
  • How to present your performance data and clinical data in a succinct, comprehensive manner
  • How to communicate and resolve different opinions between the submitter and FDA reviewer(s).
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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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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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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