Regulatory Submission Module 5: Submission Review and Outcomes

In this module, you will learn what happens to your submission once it is received by FDA. Learn what transpires during this process so you can be proactive and not reactive to FDA decisions. Also, receive perspectives from FDA on what is often lacking from industry in 510(k) submissions.
 

Expert Faculty

Phil Phillips
President
Phillips Consulting Group

Marjorie Shulman
Director, Premarket Notification 510(k) Program
FDA

(Expert faculty titles and companies may have changed since the time of recording.)
 

Level

Intermediate
 

Learning Impact

Upon completion of this training, participants will:

  • Gain insight to the FDA review process and what outcomes to expect
  • Learn how to proactively prepare for FDA correspondence following their submission
  • Hear directly from FDA about what is often lacking in 510(k) submissions


Certification

Certificate of Completion: Each participant will receive a Certificate of Completion for .1 CEUs upon viewing the webinar course and returning a completed evaluation form.

 

Price

$99 per module
$500 for entire series (Receive a 15% discount for purchasing all six modules)