Recorded Webinar: How to submit a 510(k) and get it cleared from FDA

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Webinar 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 payment)

SPEAKER: David Lim

This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA.

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 makers understand the recent changes and be able to submit a 510(k) to successfully clear it.

You will leave empowered at the end of the webinar in a way that you would submit your 510(k) using CAC-SI method, leading to your successful clearance of your 510(k).

Why should you attend: Successful prosecution of your 510(k) submission can save millions of dollars for your businesses. This webinar will discuss various circumstances, each of which will help you to prosecute your 510(k)s better before the FDA.

Areas Covered in the Session:
- Applicable Statute(s) and regulations for 510(k)s
- How to identify a 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.

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 (, 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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