FDA 510(k) Update: Recent Trends and Good Practices Compliant with eCopy and RTA policy

Duration: 60 Minutes
This webinar is intended to get familiar with the recent 510(k) trends and to help you implement good practices for your successful 510(k) preparation, submission and clearance.
FDA 510(k) Update
Instructor: David Lim
Product ID: 500129
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 510(k) trends and exercise good practices in a way to facilitate the review process for a successful clearance.

This webinar will help you prepare and submit your 510(k)s in an efficient and effective way.

Why Should you Attend:
Understanding recent 510(k) trends and implementing good practices will greatly help industry to prepare and submit a 510(k) for successful clearance from FDA, saving millions of dollars for your business. This webinar will help you get familiar with recent 510(k) trends and good practices compliant with cCopy and RTA policy requirements. If you are engaged in marketing of your medical products in the US, it is a must to attend this webinar.

Objectives of the Presentation:
  • 510(k): governing statute(s) and regulations
  • Definitions and device classification
  • Intended use(s)
  • When/who is required to submit a 510(k)
  • How to identify a suitable predicate device(s), if any
  • 510(k) eCopy requirements
  • Refuse to accept policy for 510(k)s
  • 510(k) contents and format: building a compelling 510(k) package
  • Demonstrating substantial equivalence
  • Addressing relevant and applicable regulatory requirements
  • Improving 510(k) submission quality based on common pitfalls
  • Responding to FDA’s request of additional information
  • Resolving 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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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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