Description: As part of the FDA Reauthorization Act (FDARA) and Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA committed to developing “electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.” Since then, FDA has issued draft and final guidance documents on electronic submissions for medical devices, developed the electronic Submission Template and Resource (eSTAR), and launched the voluntary eSTAR Program. This interactive template may be used to prepare 510(k) and De Novo submissions. It is believed use of this template will eventually become required.
In this session, a medical device consultant and former FDA reviewer provides insight on how to participate in the eSTAR program and walks through key features of the eSTAR template. The discussion includes:
· A brief overview of the eSTAR program; · A walkthrough of the eSTAR template and its features; and · Important tips and considerations when preparing submissions and ways to streamline use of the eSTAR template.
Learning Objectives:
Understand the purpose of the eSTAR program and which premarket submissions are eligible
Identify the key requirements and limitations of the eSTAR template
Understand how to properly complete and submit the eSTAR template to FDA for review