At this workshop, Dr. David Lim will walk you through to get familiar with the following subject areas.
510(k) Format and Contents
This workshop is intended to provide guidance on how to format 510(k) submissions including necessary contents to proactively facilitate the FDA review process for medical devices including in vitro diagnostic devices.
Why Should You Attend:
Understanding regulatory requirements and submission quality of 510(k)s adequately addressing regulatory requirements will greatly facilitate the regulatory review process, leading to fast marketing clearance and saving millions of dollars to organizations!
At this workshop, you will get familiar with 510(k) submissions concerning medical devices including in vitro diagnostic medical devices.
The following key areas will be discussed during workshop:
- Federal Statutes and Regulations Governing Medical Devices in the US
- 510(k) Format and Contents for Various Device Types Including In Vitro Diagnostic Devices
Added by complianceonlinecom on October 19, 2012