Determining when to utilize the Pre-Submissions Q-Submission (Pre-Sub) Process

In many cases, a manufacturer must submit a marketing submission (such as a 510(k)) to the U.S. Food and Drug Administration (FDA) and have it authorized before they can start selling that device in the U.S. But what if a manufacturer has questions about what the U.S. FDA will expect to substantiate the safety and effectiveness of the device? A Pre-Submission Q-Submission (Pre-Sub) is an opportunity to interact with the FDA to obtain its feedback.

Pre-Subs may be utilized to confirm testing requirements, clinical trial design expectations, real-world evidence evaluation for the expansion of indications for use and for other purposes. We at Emergo by UL will share practical information intended to equip manufacturers with how to determine when a Pre-Sub is best utilized and how to optimize a Pre-Sub, enabling the FDA to provide actionable feedback.  

About the presenter

Sarah Marie Fitzgerald, U.S. regulatory program manager and senior RA/QA consultant

Sarah Marie Fitzgerald leads U.S. regulatory services at Emergo by UL. She has 20 years of experience in medical device regulatory and quality affairs, primarily in the U.S. Fitzgerald has worked with a wide variety of medical devices and other regulated products. Her background covers global regulatory strategy, product support from concept to obsolescence, regulatory premarket submissions, product regulatory due diligence assessments, advertising and promotional support, auditing, and quality management system implementation and improvement. Fitzgerald is a member of the Regulatory Affairs Professional Society (RAPS), maintains a U.S. Regulatory Affairs Certification (RAC), and has a Master of Science in Regulatory Affairs.