“
The FDA medical device submission process can be an overwhelming, often complicated and confusing pathway to navigate for academic researchers who lack the extensive resources often available to pharma. We are indeed fortunate to have the skills and expertise of the MPSS staff to assist researchers at Vanderbilt. They have provided guidance, assurance and feedback throughout the entire process from pre-submission to IDE submission to FDA interactions and eventual FDA reporting requirements for an approved IDE. Without their help, the Department of Otolaryngology would not have one approved IDE with a second currently under review. I cannot thank MPSS enough for always being willing to answer questions, interpret regulations and guidance, and offer support along the journey, from initial idea formulation to eventual clinical trial.
