MassMEDIC Webinar: FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert

When: « Back to Calendar September 27, 2017 @ 12:00 pm - 1:00 pm
Where: Webinar
Categories: MassMEDIC Events

Register for free here.

MassMEDIC is pleased to team up with Right Submission and FDA Attorney Jeffrey N. Gibbs of Hyman, Phelps & McNamara, P.C. to bring you this webinar, focused on legal questions you might have relative to FDA product submissions.

Questions such as:

  • From a legal perspective what are common mistakes submitters make in FDA submissions?
  • What recent legal cases has CDRH been involved in and how have they turned out?
  • Is the confidentiality text we copy paste into our submissions legally binding and what happens if we don’t include it? When should we include it?

This is an extraordinary opportunity to get your legal questions about FDA device submissions answered.  You can submit your own questions in advance of the webinar and we will pose them anonymously during the webinar.  Or send them to us during the webinar, and we’ll be sure to ask our expert.

Moderator: Juan Carlos Serna, Co-Founder & CEO, Right Submission
Presenter: Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara 

Jeffrey N. Gibbs is a Director in the Washington, D.C. law firm of Hyman, Phelps & McNamara, P.C.  Before entering private practice, he was an Associate Chief Counsel for Enforcement at the Food and Drug Administration.  Jeff also served as a Special Assistant United States Attorney in the District of Columbia in the Civil Division.  He is currently Chairman of FDLI’s Board of Directors and was previously FDLI’s General Counsel.

Since entering private practice, Jeff has assisted in vitro diagnostic and medical device companies with a variety of regulatory issues, including FDA product approval, product labeling, clinical studies, promotional and marketing programs, product appeals and enforcement actions.  He received FDLI’s Distinguished Service and Leadership Award in 2013, and LMG Life Science’s Star Award in 2016.  Jeff previously served on the Human Subjects Review Board of George Mason University, and has written and spoken extensively on a wide variety of FDA regulatory topics.




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