subject: Raps Pre-approved Webinar On 510(k): Format And Contents From Globalcompliancepanel [print this page] Description: Description:
A 510 (K) premarket notification is the most common route to the market for a medical device, including in-vitro diagnostics (IVDs). It is therefore very important that a firms 510 (K) should be to the regulatory standards and be able to achieve quality submission. Firms that accomplish this will be able to save costs running into millions of dollars, since their review process will be much faster.
This webinar will give participants an understanding of how to come out with a 510 (K) submission that adequately addresses compliance issues and standards. It will lead to an enhanced understanding of how to get the review process streamlined, as a result of which the approval is gained in a faster manner.
A basic requirement of the FDA is that a 510 (K) premarket submission shoulddemonstrate that the subject device (to be marketed) is substantially equivalent (at least as safe and effective) to a legally marketed device (predicate device). That is, a 510(K) 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).
For this to happen, medical device manufacturers should understand the intricacies of 510 (K) submissions, which is what this webinar will impart. It will acquaint them with the use of the CAC-SI method, which will facilitate the streamlined review of a 510(K) submission.
Dr. David 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 obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal, Science.
Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products).
In 2009, Dr. Lim served as a member during the FDAs Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail.
