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Now Available: Voluntary Use of eSTAR for 513(g) requests for information

The U.S. Food and Drug Administration (FDA)’s electronic Submission Template And Resource (eSTAR) is now available for voluntary use for 513(g) requests for information to CDRH.

eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review.

Questions?

If you have questions about eSTAR, contact the Division of Industry and Consumer Education.