FDA eSTAR – From Planning to Submission

eSTAR – From Planning to Submission

The course focuses on understanding the FDA eSTAR framework and how it is used for the preparation and submission of medical device applications.
It reviews how eSTAR can be applied throughout the submission process - from early planning, through structuring submission content and documentation, to managing interactions with the FDA, including Additional Information requests.
The course emphasizes the use of eSTAR as a structured and supportive working framework, beyond the technical aspects of completing the form.

How will I benefit?

• A clear understanding of eSTAR as a working framework, not just a technical form
• Familiarity with the structure and underlying logic of the eSTAR template
• Ability to use the eSTAR structure to plan submission scope, documentation, and testing requirements
• Early identification of regulatory gaps, requirements, and risks
• Understanding how eSTAR structure supports consistency across the submission and during Additional Information responses

Who Should Attend

Regulatory professionals and other stakeholders involved in medical device submissions to the FDA.

Basic Requirements - Background in FDA requirements for medical devices and submission processes.

About the tutor: 

Avital Levertov - Regulatory Affairs Specialist for the U.S. Medical Device Market.

With over 15 years of experience in the medical device industry, Avital specializes in U.S. FDA regulations, including premarket applications via eCOPY and eSTAR,

pre-submissions, FDA inspections, and handling Reports of Correction and Removals. She has led complex submissions, built effective regulatory strategies, and has been directly involved in all regulatory stages — from early development through FDA submissions to post-market activities. Avital delivers practical, experience-based insights to help professionals successfully navigate U.S. regulatory requirements.