Regulatory Submission Module 6: Changes that Trigger Post-Market Submissions

Your small changes may add up to a new product in the eyes of the FDA. This module provides a deeper understanding of identifying the varying sources that may drive device modifications, conducting a risk-based approach to review the modifications before they are initiated and recognizing the triggers that prompt regulatory submission action. Topics covered in this session include assessment of design changes as well as inputs that prompt these changes.

 

Expert Faculty

Bill Brodbeck
Director, Regulatory Affairs
STERIS

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

Level

Intermediate
 

Learning Impact

Upon completion of this training, participants will:

  • Determine when it is necessary to submit a new 510(k) or revise an existing one
  • Understand how design changes affect their submission


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)