Medical DevicesLast reviewed April 2026

electronic Submission Template And Resource(eSTAR)

FDA's interactive PDF template required for all 510(k) submissions and extended to De Novo classification requests.

Usage Examples

The team exported the finalized eSTAR package to the CDRH Portal ahead of the filing deadline.
eSTAR's built-in validation caught three missing attachments before submission.
FDA released an updated eSTAR template; in-progress submissions migrated to the new version.

What is eSTAR?

eSTAR is an interactive PDF-based submission template issued by FDA CDRH that guides sponsors through device submission preparation. Sponsors fill in required fields directly in the PDF, attach supporting documentation, and submit through the CDRH Portal. FDA mandated eSTAR for all 510(k) submissions as of October 1, 2023, and extended the requirement to De Novo classification requests in 2024.

Unlike freeform Word-based submissions of the past, eSTAR performs built-in structural validation: missing required fields, broken cross-references, and unsigned sections block submission. This reduces Refuse to Accept (RTA) notices driven by obvious completeness issues.

eSTAR is the submission template, not a content system. Sponsors still need to author predicate comparisons, performance testing summaries, labeling, and other content elsewhere and then populate eSTAR with the finalized material.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 807, FDCA SECTION 510K.

FDA CDRHEMAHealth Canada

When This Matters

The team exported the finalized eSTAR package to the CDRH Portal ahead of the filing deadline.
eSTAR's built-in validation caught three missing attachments before submission.
FDA released an updated eSTAR template; in-progress submissions migrated to the new version.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 807FDCA SECTION 510K

Frequently Asked Questions

eSTAR is the template used to file a 510(k), not the 510(k) itself. A 510(k) is the premarket notification to FDA; eSTAR is the interactive PDF format FDA requires that notification to be delivered in.

Yes. As of October 1, 2023, all 510(k) submissions to FDA must use eSTAR. Paper and generic electronic submissions are no longer accepted for this pathway.

eSTAR currently supports 510(k) (Traditional, Abbreviated, Special) and De Novo classification requests. PMA submissions use a different electronic format. Q-Submissions (Pre-Submissions) do not use eSTAR.