Webinar 2013 - FDA 510(k): Preparation, Submission, and Clearance - Webinar by GlobalCompliancePanel

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).
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 and be able to prepare high quality 510(k) applications: in particular, 510(k) format and contents.
In this webinar, you will learn how to prepare for your next 510(k) and submit it for a successful clearance using CAC-SI method, facilitating the streamlined review of your 510(k) submission.
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. This webinar will discuss how to prepare a 510(k), submit and clear the 510(k) by proactively facilitating the review process.
Areas Covered in the Session:
510(k): governing statute(s) and regulations
Definitions and device classification
Intended 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)s
510(k) eCopy program
510(k) contents based on products
How to demonstrate substantial equivalence
How 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.
510(k) submission quality for product(s).
Responding to FDA's request of additional information.
Resolving different opinions between the submitter and FDA reviewer(s).
Who Will 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
Dr. 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.
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Event Link - http://bit.ly/15hmVd6