510k How To Navigate Through Hurdles And Get It Cleared Description: This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA. The premarket notification [510(k)], which is made to US FDA, is the most common pathway to market for medical devices. The 510(k) premarket submission is 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). During the 510(k) processes, there could be lots of hurdles to overcome for clearance. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand the 510(k) processes with awareness of potential hurdles and be able to prepare quality 510(k) submissions in a way to expedite the review process and subsequent clearance. This webinar will help you get familiar with the 510(k) processes and how to navigate through the hurdles inherent in the process. At the end of the webinar, you will leave with greatly improved awareness in that you would take or choose to take different approaches when preparing your next 510(k)s. Objectives of the Presentation: Governing Statute(s) and Regulations Definitions Device Classification When and Who should submit 510(k)s (Traditional, Special, or Abbreviated) How to identify a suitable predicate device(s), if any How to demonstrate substantial equivalence 510(k) Program, Processes, and Decision points during 510(k) review Differences in contents of 510(k)s based on products Common deficiencies (poor submissions) vs. quality submissions How to identify and address regulatory requirements relevant and applicable to the product(s) How to address potential safety issues How to present your performance data and clinical data in a succinct, comprehensive manner How to communicate and resolve different opinions between the submitter and FDA reviewer(s). Who can 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
Training Options Duration: 60 Minutes Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $288.00