510(k) Submission: Contents and Format for Medical Devices

Duration: 60 Minutes
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (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).
510(k) Program Training
Instructor: David Lim
Product ID: 500002

For the past few years, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. Thus, to bring medical device products to the US market fast, it is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the new requirements to greatly facilitate the review process in a proactive and streamlined manner. This webinar will help you to greatly improve your 510(k) preparation, strategy and submission quality by leveraging practical and actionable strategy.

This webinar will discuss:
  • 510(k) program and recent changes (e.g., 510(k) actions and improvements)
  • How to identify and assess the regulatory requirements
  • How to meet the regulatory requirements
  • How to increase 510(k) submission quality
  • How to format a 510(k) submission to proactively facilitate the review process
  • Some template forms, which are applicable for both general medical devices and in vitro diagnostic devices, will be discussed.
Why Should you Attend:
If you don’t know the answers to the following questions, you should attend this webinar.
  • What is 510(k)? What is a 510(k) submission?
  • What are the applicable federal statutes and implementing regulations for 510(k) submissions?
  • How the medical devices are classified?
  • What are the challenges and hurdles during the 510(k) preparation, submission, and review process?
  • How to identify applicable regulatory requirements?
  • How to address applicable regulatory requirements (e.g., performance requirements including clinical studies, if applicable)?
  • What are the common deficiencies in 510(k) submissions?
  • How to format a 510(k) submission using the CAC-SI method?
Objectives of the Presentation:
  • FDA regulations applicable to a 510(k) submission
  • 510(k) program and recent changes in the 510(k) program
  • 510(k) regulatory requirements
  • 510(k) submission requirements for medical devices and in vitro diagnostic devices
  • List of applicable FDA guidance documents
  • List of applicable reference standards
  • Systematic methods to increase 510(k) submission quality.
  • Formatting a 510(k) for submission
  • 510(k) contents for medical devices and in vitro diagnostic devices.
  • Instructor’s unique practical and actionable strategy
  • CAC-SI method
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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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