Overview: This webinar is intended to demonstrate how to prepare a 510(k), submit, and get it cleared in a manner with increased quality so that the review process can be expedited. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices. Pursuant to the section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), the 510(k) premarket submission is made to 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). 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). Why Should You Attend: A premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices. It is crucial that your 510(k) preparation should be adequate to achieve quality submission, thereby leading to successful clearance by expediting the review process. Areas Covered in the Session:510(k): governing statute(s) and regulationsDefinitions and device classificationIntended use(s)When and who are required to submit a 510(k)How to identify a suitable predicate device(s), if any.Refuse to accept policy for 510(k)s510(k) eCopy program510(k) contents based on productsHow to demonstrate substantial equivalenceHow to identify regulatory requirements relevant and applicable to the product(s).How to address the relevant and applicable regulatory requirements.Who Will Benefit:Regulatory Affairs Managers, Directors and VPsClinical Affairs Managers, Directors and VPsQuality Managers, Directors and VPsQuality Managers, Directors and VPsCompliance Managers and DirectorsSales and Marketing Managers, Directors, and VPsComplaint Handling and Risk Management Managers and DirectorsSite Managers, Directors, and ConsultantsSenior and Executive ManagementCompliance Officers and Legal CounselBusiness Development Managers, Directors, and VPsDr. 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.