FDA issues draft guidance for electronic IDE submissions via eSTAR

The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Resource (eSTAR) format. The document details the steps and requirements for electronic filing as the agency moves toward a fully electronic submission process.

The guidance is intended to streamline the IDE submission workflow and improve consistency across submissions. It provides technical specifications, data formatting standards, and procedural recommendations for using eSTAR.

The FDA is seeking comments from industry stakeholders on the draft guidance before finalizing the policy, encouraging developers to review the recommendations and provide feedback.