LiveWebinar : 510(k): Format and Contents by compliance2go

Houston, TX, September 30, 2012 --(PR.com)-- 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 changes and be able to prepare for a 510(k) in a way to expedite the review process and subsequent clearance.

At the end of the webinar, you will feel empowered in that you would take or choose to take different approaches to prepare for and submit your next 510(k).

Why you should attend

This webinar is intended to help you get familiar with 510(k) format and contents to ensure a successful 510(k) submission.

To avoid unnecessary delays and for the successful review, it is crucial that your 510(k) preparation should be adequate in terms of format and contents, thereby significantly contributing to expediting the review process and saving millions of dollars for your businesses.

Areas Covered In the Seminar

Statute(s) and regulations governing 510(k)
Definitions and medical device classification including in vitro diagnostic medical devices
Who should submit 510(k)s and when required to submit 510(k)s
How to identify a suitable 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.
How to respond to FDA’s request of additional information.
How to resolve different opinions between the submitter and FDA reviewer(s).

Who will benefit

· Regulatory Affairs Associates, Specialists, Managers, Directors and VPs
· Quality Associates, Specialists, Engineers, Managers, Directors and VPs
· Compliance Specialists and Officers
· Research and Development (R&D) Managers, Directors and VPs
· Product and Development (P&D) Managers, Directors and VPs
· Complaint Handling and Risk Management Managers and Directors
· Sales and Marketing Managers and Directors
· Clinical Affairs Managers and Directors
· Site Managers, Directors, and Consultants
· Senior and Executive Management
· Legal Counsel
· Anyone Interested in learning about 510(k) process and submission

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-90 Minutes Live Presentation

About Speaker

Dr. David 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, he has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (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, Regulatory Doctor, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. 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. Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, 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). He is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs.