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# Guide on 510(k) eSubmission Template
- URL: https://www.fdaweb.com/guide-on-510-k-esubmission-template/
- Published: 2023-10-03T12:00:00.000Z
- Updated: 2026-09-14T18:59:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155470

FDA is making available a [final guidance](https://www.fda.gov/media/152429/download?ref=fdaweb.com) entitled “Electronic Submission Template for Medical Device 510(k) Submissions.” The document was developed as part of the agency’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.

The guidance discusses the electronic submission template, eSTAR, which is the only currently available electronic submission template to help prepare 510(k) electronic submissions. eSTAR comprises a collection of questions, text, logic, and prompts within the template to guide users through preparing a “complete” submission. “eSTAR is highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes targeted questions designed to collect specific data and information from the submitter,” it says. “Finally, eSTAR is structured to collect and assemble content in the 510(k) submission as an electronic submission that closely follows the content of the “SMART” 510(k) review memo template used by CDRH reviewers.”