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# eSTAR Now Available for Device 513(g) Requests
- URL: https://www.fdaweb.com/estar-now-available-for-device-513-g-requests/
- Published: 2024-03-29T12:00:00.000Z
- Updated: 2026-09-14T14:26:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156663

FDA says its electronic Submission Template And Resource (eSTAR) [system](https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program?utm%5Fmedium=email&utm%5Fsource=govdelivery) is now available for voluntary 513(g) requests for information sent to CDRH. 513(g) requests for information involve the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act.

The agency published a [2019 guidance](https://www.fda.gov/media/78456/download?ref=fdaweb.com) entitled “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act” that established procedures for submitting, reviewing and responding to such requests.

The agency says eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. It guides the submitter to ensure they provide the necessary details for the submission. It is also intended to complement the reviewers' internal Submission Memo And Review Template that is used to review the submission (the questions correlate), “so the reviewer is getting what is expected,” according to FDA.