eSTAR Templates by Submission Type
eSTAR (Electronic Submission Template And Resource) is FDA's mandatory electronic submission format for premarket device submissions. All Traditional, Abbreviated, and Special 510(k)s and De Novo requests submitted from October 1, 2023 must use eSTAR.
Available eSTAR templates
| Submission type | Template name | Required since |
|---|---|---|
| Traditional 510(k) | eSTAR 510(k) — Traditional | Oct 1, 2023 |
| Abbreviated 510(k) | eSTAR 510(k) — Abbreviated | Oct 1, 2023 |
| Special 510(k) | eSTAR 510(k) — Special | Oct 1, 2023 |
| De Novo request | eSTAR De Novo | Oct 1, 2023 |
| Humanitarian Device Exemption | eSTAR HDE | Check FDA site |
| PMA | eSTAR PMA (select modules) | Phased rollout |
Download all templates: fda.gov — eSTAR Templates
How eSTAR works
eSTAR is a fillable interactive PDF:
- Open in Adobe Acrobat Reader (specific version per template instructions)
- Answer guided questions — conditional logic hides irrelevant sections automatically
- Attach supporting files (test reports, labelling, etc.) within the template
- Export / flatten the completed PDF
- Submit via the CDRH eCopy Program (digital copy + paper copy where required)
Key eSTAR sections (Traditional 510(k))
| Section | Content |
|---|---|
| Device overview | Device description, indications for use, intended use statement |
| Substantial equivalence | Predicate identification, comparison table, SE discussion |
| Testing | Performance testing by category (electrical, biocompatibility, software, sterility, etc.) |
| Labelling | Draft label, IFU, carton |
| Truthful & accurate | Certifications |
| 510(k) summary | Public-facing summary |
Common eSTAR mistakes
| Mistake | How to avoid |
|---|---|
| Wrong PDF version | Always download the latest version of the template — check FDA's page before starting |
| Incomplete attachments | Every test report referenced in the template must be attached within the PDF |
| Excessive file size | Compress images in test reports; FDA may return oversized submissions |
| Missing FDA Form 3881 | The Indications for Use form is a required separate document — attach it |
| Submitting expired template version | Templates are updated periodically — re-download if in doubt |