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eSTAR — Electronic Submission Template And Resource

US-unique

eSTAR is FDA's mandatory electronic submission format for 510(k), De Novo, and certain PMA submissions. It replaced the traditional PDF/Word submission format and is a US-specific requirement.

What is eSTAR?​

eSTAR (Electronic Submission Template And Resource) is an interactive PDF-based template system developed by FDA to standardise the format and content of premarket device submissions. Since October 1, 2023, all Traditional and Abbreviated 510(k)s, and De Novo requests, must be submitted using eSTAR.

How eSTAR works​

eSTAR is an interactive PDF that:

  • Guides you through all required sections using guided question-and-answer format
  • Applies conditional logic — sections that are not applicable are automatically hidden
  • Validates that required fields are complete before allowing export
  • Generates a structured PDF that FDA reviewers can navigate efficiently
  • Links to FDA guidance documents within the template

eSTAR templates available​

Submission typeeSTAR template
Traditional 510(k)eSTAR 510(k) Template
Abbreviated 510(k)eSTAR Abbreviated 510(k) Template
Special 510(k)eSTAR Special 510(k) Template
De Novo requesteSTAR De Novo Template
Humanitarian Device Exemption (HDE)eSTAR HDE Template

Submitting via eSTAR​

  1. Download the appropriate eSTAR template from FDA's website
  2. Complete all required sections within the template
  3. Attach supporting documents (test reports, labelling, etc.) within the template
  4. Export the final eSTAR PDF
  5. Submit via CDRH's eCopy Program — a digital copy on physical media (CD/DVD/USB) accompanied by the eCopy cover sheet, plus a paper copy where required

FDA is transitioning toward fully electronic submissions — check current instructions before submitting.

Common eSTAR issues​

  • File size: Keep supporting attachments to minimum necessary — large submissions may be returned
  • Software/PDF version: Use the PDF viewer version specified in the template instructions
  • Version control: Always download the latest version of the template — older versions may be rejected
  • Attachments: All attachments must be referenced within the eSTAR PDF (not loose files)

Official resources​