510(k): Format, Contents and Case Studies

Duration: 60 Minutes
This webinar is intended to demonstrate how to prepare a 510(k) in a manner to facilitate the review and for successful clearance.
510(k) submission
Instructor: David Lim
Product ID: 500043
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices. The 510(k) premarket submission is made to US FDA 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) as described in 21 CFR 807.92(a)(3). In other words, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.

To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand the recent changes and be able to prepare for a 510(k) in a way to expedite the review process and successful clearance. At the end of the webinar, you will feel empowered in that you would take or choose to take different approaches to prepare for and submit your next 510(k).

Objectives of the Presentation:
  • Statute(s) and regulations governing 510(k)
  • Definitions and medical device classification including in vitro diagnostic medical devices
  • Who should submit 510(k)s and when required to submit 510(k)s
  • How to identify a suitable predicate device(s), if any
  • How to demonstrate substantial equivalence
  • Recent changes in the 510(k) program
  • Decision points during 510(k) review
  • Differences in contents of 510(k)s based on products
  • How to identify regulatory requirements relevant and applicable to the product(s)
  • How to address the relevant and applicable regulatory requirements
  • How to present your performance data and clinical data in a succinct, comprehensive manner
  • How to increase 510(k) submission quality for a product
  • How to respond to FDA’s request of additional information
  • How to resolve different opinions between the submitter and FDA reviewer(s).
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  • Quality Professionals (Associates, Specialists, Managers, Directors or VPs)
  • R&D (Engineers, Scientists, Managers, Directors or VPs)
  • Complaint and Risk Management Personnel
  • Consultants
  • Contractors/Subcontractors
  • CEOs
  • VPs
  • Clinical Affairs (Associates, Specialists, Managers, Directors or VPs)
  • Other Interested Parties
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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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