The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions

Description: The FDA eSTAR is currently voluntary for 510(k) and De Novo submissions to CDRH and CBER, but beginning October 1, 2023, it will be required for all new 510(k) submissions. eSTAR stands for “electronic Submission Template and Resource.” The FDA provides two eStar templates for downloading, one for IVDs and one for non-IVDs. The eSTAR templates are interactive PDF documents that guide you through submission preparation by automatically generating required information fields based on responses to questions. Information is provided in a combination of text fields and attachments. The content requirements in the eSTAR template are comparable to an eCopy 510(k) or De Novo submission, however, the preparation differs. In this session, we will share insights to help you strategically prepare an eSTAR 510(k) or De Novo submission, such as managing text field content and limitations, organizing and naming attachments, creating advocacy in a modular format, options for creating the 510(k) Summary, and leveraging the Cover Letter and Executive Summary to your advantage. You will learn practical tactics to optimize the quality and facilitate review of your submission. We will also provide an overview of the FDA’s review process for eSTAR submissions and strategies for how to manage submission updates in response to requests for Additional Information.