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Evaluation ViewAttendees 35

Solutions Circle

Devices (includes Medical Devices and In Vitro Diagnostics)

Conversation Starters

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

Thursday, October 5, 2023
12:05 PM – 12:35 PM EDT
Location/Room: Exhibit Hall: Solutions Circles
Intermediate Level
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. In this solutions circle, we will discuss insights to help you strategically prepare an eSTAR submission, such as tips for 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. This solutions circle will provide a summary version of the eSTAR session to be held in the afternoon.

Learning Objectives:

  • Upon completion, participants will be able to understand what an eSTAR submission is and what submission types it can be used for.
  • Upon completion, participants will be able to understand how the eSTAR templates are designed, their content requirements, and how to use the built in help features.
  • Upon completion, participants will be aware of tips and tricks to appropriately advocate for their product when using the eSTAR submission format.