What is FDA eSTAR?

The electronic Submission Template And Resource (eSTAR) is an interactive PDF form that allows medical device applicants to prepare and submit their submission to the U.S. Food and Drug Administration (US FDA). The eSTAR aims to improve the quality of medical device submissions as it supports applicants in providing comprehensive data for premarket review by the US FDA. Applicants can make sure their submissions are completed through the standardized format that the eSTAR has and the US FDA is able to conduct premarket reviews more efficiently as a result.

What are the benefits of the electronic Submission Template and Resource?

The eSTAR provides several benefits to medical device applicants:

• Provides applicants with the necessary guidance to ensure they submit the required details for submission
• Complements the internal Submission Memo and Review Template (SMART) which is internally correlated to for reviewing the submission, ensuring that the reviewer is getting what is required
• Standardized format allowing easier access to information (for reviewer and submitter)
• Automates several aspects of the submission and mitigates a “Refuse to Accept” review by the FDA
• Has built-in databases to help ensure information is filled accurately and is relevant
• Is a comprehensive resource that consolidates required information and links that are needed for the preparation of the submission

What are some key considerations for preparing an eSTAR submission?

The FDA provides step-by-step guidance for preparing a submission using eSTAR. Some of the key considerations for preparing an eSTAR submission include the following:

• Download the eSTAR PDF template from the US FDA website
• Read & understand the directions before starting the submission
• Fill the template accordingly
• Keep the submission less than 4GB as the portal cannot receive eSTARs that are bigger than total 4GB. Attachments must be less than 1GB.

DDReg’s Capabilities

DDReg provides expert support to medical device companies that are looking to submit eSTARs to the US FDA. The team is equipped with in-depth technical knowledge and regulatory expertise for submissions to the US FDA, including compilation, review, validation, and submissions that are compliant and streamlined.