U.S. FDA Pre-Submissions

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

In this webinar, the presenter helps attendees develop a greater understanding of the Pre-Submission process by reviewing relevant sections of the updated guidance.

Webinar date

Nov. 9, 2023

Speaker

Heather Crawford, manager, Quality & Regulatory Affairs Program

The U.S. Food and Drug Administration (FDA) updated its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” on June 2, 2023. While the guidance identifies several types of Q-Submissions available where one can request feedback from the U.S. FDA, the current webinar will focus on Pre-Submissions. A Pre-Submission includes a request for feedback from the FDA as written feedback or as written feedback and a meeting before a pre-market submission. 

This webinar will help you gain a better understanding of the Pre-Submission process by reviewing relevant sections of the updated guidance. You will learn more about the Early Submission Requests eSTAR (PreSTAR) Beta Version for Pre-Submissions.

About the presenter

Heather Crawford, manager, Quality & Regulatory Affairs Program

Heather Crawford has over 20 years of experience in the medical device industry, specializing in regulatory affairs and quality management systems. Crawford’s background includes developing and contributing to Clinical Evaluation Reports, EU Technical Files and Design Dossiers, U.S. Pre-market Approval (PMA) applications, and U.S. 510(k) submissions. She also has extensive experience in standards development and contributed to the U.S. position on standards, including ISO 13485 and ISO 9001. She works directly with customers on their quality and regulatory projects. She also peer reviews reports and regulatory filings for her colleagues. Prior to joining Emergo by UL, Crawford worked in the industry, focusing on implantable devices and new products.