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510k Submission and Clearance Description: A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (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) as described in 21 CFR 807.92(a)(3). It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the new requirements. What triggers the review time most is 510(k) submission quality, which greatly helps to expedite the review process. To facilitate the review process in a proactive and streamlined manner, this webinar is intended to walk you through strategies, tools, and methods for a successful 510(k) submission and clearance. Why Should you Attend: If you don't know the answers to the following questions, you should attend this webinar. Applicable statute(s) and regulations What is 510(k)? What are the regulatory requirements for 510(k) submission? How to choose suitable predicate(s) How the medical devices are classified What are the common deficiencies in 510(k) submissions? How to improve 510(k) submission quality and address the applicable regulatory requirements How to effectively use the FDA guidance documents and voluntary standards How to ask and respond to questions and communicate with the FDA reviewers How to resolve different opinions in interpreting the requirements How to facilitate the review process to get it cleared fast. Objectives of the Presentation: Applicable statute(s) and regulations What is 510(k)? What are the regulatory requirements for 510(k) submission? How to choose suitable predicate(s) How the medical devices are classified What are the common deficiencies in 510(k) submissions? How to improve 510(k) submission quality and address the applicable regulatory requirements How to effectively use the FDA guidance documents and voluntary standards How to ask and respond to questions and communicate with the FDA reviewers How to resolve different opinions in interpreting the requirements How to facilitate the review process to get it cleared fast.


Who can Benefit: Regulatory Affairs Associates, Specialists, Managers, Directors and VPs Quality Associates, Specialists, Engineers, Managers, Directors and VPs Compliance Specialists and Officers Research and Development (R&D) Managers, Directors and VPs Product and Development (P&D) Managers, Directors and VPs Complaint Handling and Risk Management Managers and Directors Sales and Marketing Managers and Directors Clinical Affairs Managers and Directors Site Managers, Directors, and Consultants Senior and Executive Management Legal Counsel Anyone Interested in learning about 510(k) process and submission.

Training Options Duration: 60 Minutes Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $288.00


510k Submission and Clearance