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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.
The eSTAR provides several benefits to medical device applicants:
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:
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.