FDA 510(k): Trends, Hurdles, Submission and Clearance

Duration: 60 Minutes
This webinar is intended to help you get familiar with the recent FDA 510(k) trends, hurdles, and submission and clearance.
Premarket Notification Requirements
Instructor: David Lim
Product ID: 500207

The section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the premarket notification [510(k)] requirements. The premarket notification, 510(k), is the most common pathway to market for medical devices. A 510(k) 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(s) 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, implementing e-Copy and RTA policy requirements. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand the current trends and hurdles so that 510(k) submission and clearance can be less burdensome, significantly contributing to saving a significant amount of time, energy and resources.

This webinar will help you get updated and familiar with the recent 510(k) trends, hurdles and good practices for 510(k) submission and clearance.

Objectives of the Presentation:
  • Statute(S) And Regulations
  • Definitions And Device Classification
  • Intended Use(s) and Predicates
  • When/Who Is Required To Submit A 510(s)
  • 510(k) e-Copy Requirements
  • Refuse To Accept Policy for 510(k)s
  • 510(k) Contents And Format
  • Demonstrating Substantial Equivalence: Requirements
  • Identifying and Addressing Regulatory Requirements
  • 510(k) Trends, Hurdles and Common Pitfalls
  • Communication with the FDA Reviewers
  • Reducing and Preventing Differing Opinions
  • Good Practices: Suggestions and Recommendations
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
$375
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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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