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Understanding the Power of the FDA Pre-Sub: Tips for a Successful Meeting

September 30, 2020

1:00 pm EDT

The submission process to the FDA can be a stressful and uncertain time for a medical device company. Delays in getting your device to market can cost millions of dollars in revenue. Changes to standards, new guidance documents, and review variability all add to the stress of a submission. The FDA pre-submission process can help reduce the stress and answer questions related to your specific device.

In this webinar, we will cover what the pre-submission process is, how to initiate a meeting, and how to prepare and run the meeting to gain the best results. We will highlight tips we have used to make partnering with the FDA a rewarding experience.

Join Thor Rollins and Matthew Jorgensen; PhD, DABT, as they cover:

  • What is a pre-submission meeting (Q-sub) with the FDA?
  • How do you set a Q-Sub?
  • How do you deliver your plan during a Q-Sub?
  • What is the meeting flow?
  • Can I challenge the FDA?
  • How do I get the most from the Q-Sub?
Thor Rollins

Thor Rollins

Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Matthew Jorgensen

Matthew Jorgensen

Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...