Regulatory Submission Module 3: Verification of the Foundation

Now that the foundation is set for the submission of your new product, it is time to verify the data that supports your 510(k). In this module gain insight to methods of collecting this important data. Understand how existing international submissions can affect your product. You will also hear FDA perspectives on pre-sub meetings and how you can best prepare yourself for them.
 

Expert Faculty

Ralph Hall
Counsel
Faegre Baker Daniels

Soma Kalb
Acting Director, IDE 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:

  • Discover where and how to collect the most important data for their 510(k)
  • Identify ways to leverage global submissions into their 510(k)
  • Listen to FDA’s perspective on pre-sub meetings and conduct theirs in line with the new guidance document


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)