Registration
May ASQ Salt Lake Event
FDA 510(k) eSTAR - Webex Event
An Overview of FDA’s 510(k) eSTAR Program
Any kind of regulatory submission can be a challenge, and a 510(k) is no exception. The question is how FDA’s new eSTAR program has impacted an already complicated process. Is it easier? Are you more or less likely to get an Additional Information Request? Get an introduction to the 510(k) submission process and learn how to navigate the eSTAR template and submission.
presented by
Catherine Langford
Catherine Langford came to quality engineering from the world of publishing. After she stumbled into a job as a technical writer for a medical device manufacturer, she took a Certified Quality Engineer prep class and was excited by the influence quality engineering principles could have on any system and environment. She earned her CQE in 2014 and then certified as a quality auditor in 2019. Catherine has since moved into a regulatory affairs role and continues to put her quality engineering and auditing skills to work in submissions and notifications, including a recent successful 510(k) clearance. She has also been a guest presenter at the University of Utah. In 2023, she served as the ASQ Salt Lake Section secretary and newsletter editor, and has served as chair since 2024. Catherine has a bachelor's in print journalism from Brigham Young University and a master's in integrated marketing communications from West Virginia University