Understanding FDAs Recent 510(k) Guidance and New Requirements

Duration: 60 Minutes
This webinar is intended to discuss the recent changes, hurdles, and requirements for premarket notification [510(k)] compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
Instructor: David Lim
Product ID: 500495

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD & C Act or the Act) describes the premarket notification requirements. The FDA [510(k)] guidance is the most common pathway to market for medical devices. The 510(k) is made 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. Recent implementation of both eCopy program and RTA policy necessitates medical device industry to pay a special attention to the 510(k) process. In addition, FDA recently finalized the 510(k) guidance.

It is imperative that the medical device manufacturers accurately understand and interpret the recent changes and the applicable regulatory requirements so that it can be adequately addressed in 510(k) s.

This webinar will provide ample opportunities to streamline your 510(k) preparation and submission in a way to adequately meet both eCopy and RTA policy and save a significant amount of time, energy, and resources.

Why Should you Attend:
  • It is important to ensure you are familiar with the latest FDA guidance so that you can demonstrate substantial equivalence of your device to a predicate(s) pursuant to the statutory requirements as set out in the FDA guidance document.
  • It is also time to ensure you streamline your 510(k) preparation, 510(k) submission and 510(k) clearance in a highly efficient, effective manner.
Objectives of the Presentation:
  • Laws and regulations
  • Definitions
  • FDA's recent guidance document
  • New 510(k) requirements
  • Refuse to accept (RTA) policy
  • eCopy program
  • Who/when it is required to submit a 510(k)
  • Regulatory requirements: performance testing
  • 510(k) content and format
  • 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).
  • Common mistakes
  • Best practices: PASS-IT solutions
Who can Benefit:
  • Regulatory affairs (associates, specialists, managers, directors or VPs)
  • 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
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • 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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