510(k): Format and Contents

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

Overview:

The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices.

Pursuant to the section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), the 510(k) premarket submission is made to 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). 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).

Thus, it is a must to adequately prepare your next 510(k) to get it successfully cleared in a timely manner, saving significant amount of your unnecessary time, energy, and other resources.

This webinar will discuss how to prepare a 510(k) quality submission including guidelines for the format and content of the 510(k). Please join and make sure you have all the bases and requirements for successful 510(k) submission package covered.

Why Should You Attend: It is crucial that device manufacturers understand 510(k) pitfalls and prepare against the pitfalls. Device firms should also consider the impact on your budget.

Thus, an adequate preparation of your next 510(k) to obtain successful clearance of your 510(k)s. This webinar will discuss how to prepare a 510(k) quality submission including guidelines for the format and content of the 510(k). Please join and make sure you have all the bases and requirements for the 510(k) submission package covered.

Areas Covered in the Session:
  • Applicable statute(s) and regulations
  • Definitions and device classification
  • When and who are required to submit a 510(k)
  • 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)

Who Will 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
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. 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 over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 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 is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.


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