Wednesday 10th April, 2013
10:00am to 11:00am
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). 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 format your next 510(k) with adequate contents 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 significantly contributing to expediting the review process and saving millions of dollars for your business. This webinar will discuss how to prepare a 510(k) including guidelines for the format and content of the 510(k).
Areas Covered in the Session:
Statute(s) and regulations governing 510(k)s
Definitions and device classification
When and who are required to submit a 510(k)
How to identify a suitable predicate device(s), if any.
How to demonstrate substantial equivalence
510(k) eCopy program
Refuse to accept policy for 510(k)s
Differences in contents of 510(k)s based on products
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.
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 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.
Livermore Common, Fremont, CA, 94539
Event Link - http://bit.ly/Yo6gy6
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