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

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

 

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About The Event

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

 


NetZealous LLC,DBA GlobalCompliancePanel 

161 Mission Falls Lane,Suite 216, Fremont, CA 94539, USA           

USA Phone:800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com


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