US FDA electronic Submission Template and Resource (eSTAR)

Beginning in 2018, the US FDA has been experimenting with a way to help industry provide a complete 510(k) premarket notification, and in 2022 they finalized their approach by publishing a final guidance document on the use of their electronic Submission Template and Resource (eSTAR). This guidance document mandates that all new 510(k) submissions, unless exempted, be provided to the FDA using eSTAR by October 1, 2023. It also allows manufacturers to use eSTAR when submitting de novo classification requests.

In this webinar, the presenter will help attendees develop a greater understanding of eSTAR and how to use it efficiently.  Additionally, the presenter will share Emergo’s perspective on eSTAR and discuss when and how it may be valuable to still use the services of a consulting agency such as Emergo. 

Presenter 

Sarah Marie Fitzgerald, U.S. Regulatory Program Manager & Senior Consultant Regulatory and Quality Affairs 

With 19 years of experience in regulatory and quality affairs, Sarah’s expertise includes regulatory strategy, regulatory submissions, and design support for a wide variety of medical devices ranging from implants to software as a medical device (SaMD). She earned an M.S. in Regulatory Affairs from Northeastern University and a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS), and has a background in biology.  

In her role with Emergo by UL, Sarah focuses on medical device support for the US FDA and has compiled dozens of submissions including 510(k), de novos, emergency use authorizations (EUAs), Q-submissions (including pre-submission, breakthrough device (BTD) designations, and safer technology program (STeP) designations), and investigational device exemptions (IDEs). Sarah also has extensive quality management system (QMS) experience and experience with other markets including the European Union, Australia, and Canada.