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eLearning: U.S. FDA Medical Device Premarket Submissions

In the last few years the U.S. Food and Drug Administration (FDA) has released many new guidance documents relating to premarket submissions.  Would you know what the most current recommendations are when preparing a 510(k) or PMA?  This eLearning program, consisting of six modules, will walk you through the requirements, best practices, and relevant regulations and guidance documents when preparing a premarket submission.  It is ideal for those new to the field of medical devices, transitioning from other industries, or looking for a refresher.

 

WHO SHOULD ATTEND?
 

This course is intended for those new to the field of medical devices, transitioning from other industries, or looking for a refresher.  No previous knowledge of medical device premarket submissions is necessary.

 

QUESTIONS?
 
  • For ordering questions, please contact AAMI’s Customer Service Center at +1-877-249-8226 (+1-240-646-7031 outside the U.S.).
  • For content or format questions, please contact Emilee Hughes at +1-703-253-8278.

To learn more about the objectives of the course, click on the links below for more information:

What is an Online Course?

The convenient format of an online course allows you to learn on your own time and from anywhere with Internet access.  As you advance through the interactive program, you’ll view presentations and videos, complete exercises, and answer quiz questions at the end of each module to test your comprehension. This program is viewable through any Internet browser with the Flash plug-in and will take approximately 5 hours to complete.

Instructor

Course Fees

  1. Online — Coming soon.
  2. Phone — Toll free 1-877-249-8226 to order with a credit card.
  3. Fax — Select and download the printer-friendly order form and fax to +1-240-396-5781.
  4. Mail — Select and download the printer-friendly order form and mail with payment to:

AAMI Publications
Online Course
PO Box 0211
Annapolis Junction, MD 20701-0211