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510(k): Format and Contents

510(k): Format and Contents - Webinar By GlobalCompliancePanel

Overview: This webinar is intended to demonstrate how to prepare a 510(k) in an adequate manner with increased quality to expedite the streamlined review process. 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). 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 significantly contributing to expediting the review process and saving millions of dollars for your businesses. Areas Covered in the Session:Statute(s) and regulations governing 510(k)sDefinitions and device classificationWhen and who are required to submit a 510(k)How to identify a suitable predicate device(s), if any.How to demonstrate substantial equivalenceRecent changes in the 510(k) program.Decision points during 510(k) reviewDifferences in contents of 510(k)s based on productsHow 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 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. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. GlobalCompliancePanelPhone: 800-447-9407Fax: 302-288-6884


11 Dec 2012 @ 10:00 am

11 Dec 2012 @ 11:00 am

Duration: 1 hours

Timezone: GMT -8:00


Online Webinar

Organised by

GlobalCompliancePanel (deactivated)

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