The FDA eSTAR Program

The FDA eSTAR Program (Electronic Submission Template and Resource) is a digital initiative launched by the U.S. Food and Drug Administration to modernize and standardize medical device regulatory submissions. Designed to simplify the preparation and review of applications such as 510(k), De Novo, and certain PMA submissions, eSTAR provides an interactive, structured template that guides applicants through the required content in a logical and user-friendly format.
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