> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Guide on Electronic Templates for IDE Applications
- URL: https://www.fdaweb.com/fda-guide-on-electronic-templates-for-ide-applications/
- Published: 2026-10-28T10:05:00.000Z
- Updated: 2026-10-28T22:05:58.000Z
- Author: David McFarland
- Tags: Devices

FDA has issued a draft guidance outlining plans to require IDE holders to use standardized electronic submission templates, extending the agency's electronic submission requirements to clinical investigations of medical devices.

The [guidance](https://www.fda.gov/media/195797/download?ref=fdaweb.com), *Electronic Submission Template for Investigational Device Exemption (IDE) Applications*, applies to IDE submissions reviewed by CDRH and CBER, including original applications, supplements, amendments and related submissions. Certain submissions, including IDE reports and amendments to those reports, would be exempt.

FDA says its electronic Submission Template and Resource (eSTAR) is currently the only available template for IDE electronic submissions. Sponsors may use eSTAR voluntarily during the transition period before the electronic format becomes mandatory.

The template relies on guided prompts intended to help sponsors assemble information required under 21 CFR Part 812, improve submission consistency and increase review efficiency.

The initiative builds on FDA's eSTAR program, launched as a pilot in February 2020, and commitments under the medical device user fee agreements to expand standardized electronic submissions.