Improving 510(k) Submission Quality
Description: This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)�) is made to US FDA. The 510(k) is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is to demonstrate that the subject device (to be marketed or new device) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). During the 510(k) preparation, improving 510(k) submission quality can save significant amount of your business time, money, and resources by avoiding encountering lots of hurdles during the review process in a predictable and foreseeable manner. To bring a product to market fast 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 510(k)s in a way to proactively expedite the review process for timely clearance, potentially saving millions of dollars to the businesses. This 60-min webinar will greatly help you improve your 510(k) submission quality, inspiring you to take or choose to take different approaches when preparing your next 510(k)s. Objectives of the Presentation: Statute(s) and regulations for 510(k)s Definitions Regulatory provisions, device classification, and product codes What actions require 510(k)s (traditional, special, or abbreviated) Who is subject to 510(k) submission 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 Quality submission requirements How to identify and address regulatory requirements and safety issues Data summary and presentation How to identify potential risks and establish risk criteria Communication, interaction and negotiation with the FDA reviewers Speaker’s methods, tools, strategies, and much more. 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