FDA eSTAR Submission Template Guide
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Build a complete, consistent eSTAR package and connect each answer to the supporting evidence for your device’s submission pathway.
What is the FDA eSTAR submission template?
The electronic Submission Template and Resource (eSTAR) is an interactive PDF used to assemble device submission information and attachments for the US FDA. It is a preparation format, while the CDRH Portal is the delivery and tracking channel for CDRH submissions. Completing the form does not establish substantial equivalence or prove that the evidence is adequate.
Start with the current FDA eSTAR program page rather than a third-party download. FDA updates the template and its available submission types. Select the IVD or non-IVD template appropriate to the product and confirm the center receiving the submission.
Which submissions require eSTAR?
| Submission | Current eSTAR position | Planning implication |
|---|---|---|
| 510(k), including covered combination-product submissions | Mandatory unless an applicable exemption applies | Use the correct product template and submission subtype |
| De Novo | Mandatory unless exempted; requirement began October 1, 2025 | Prepare a risk/control rationale rather than a predicate-based equivalence argument |
| Covered PMA applications and supplements | Available for voluntary use | Confirm eligibility of the application or supplement type |
| Q-Submissions, IDEs and 513(g) requests | PreSTAR is available voluntarily for supported request types | Do not describe all early submissions as mandatorily eSTAR |
Use the current program scope and pathway guidance together. The 510(k) electronic-template guidance and De Novo instructions set the relevant requirements. FDA’s current program page also identifies dual 510(k)/CLIA-waiver IVD submissions in its mandatory scope.
Build the evidence package before completing the form
The following is a practical preparation matrix; the actual questions depend on your responses and product.
| Workstream | Evidence to prepare | Consistency check |
|---|---|---|
| Device identity and classification | Description, models, product codes and regulatory rationale | Same device scope throughout the submission |
| Intended use and labeling | Indications, users, population, environment and draft labels/IFU | Claims match the tested configuration |
| Pathway argument | Predicate comparison for 510(k), or risk/control proposal for De Novo | Differences are explained with supporting evidence |
| Performance | Bench, electrical, biocompatibility, sterilization and other applicable reports | Test article and acceptance criteria support the claims |
| Software and cybersecurity | Architecture, verification, validation and required cybersecurity documentation | Software version and boundaries match the device description |
| Clinical and usability | Applicable clinical/performance and human-factors evidence | Users and use conditions reflect the labeling |
Do not answer “not applicable” merely to suppress an attachment request. Document the technical reason and confirm it against product-specific guidance. Cross-reference report identifiers, revisions and sections so a reviewer can follow the evidence without guessing.
Technical screening and submission readiness
Download the dynamic PDF and open it in compatible software. A browser preview is not a reliable editing environment. Assign one controlled master and a submission owner; concurrent edits can create inconsistent or lost information. Reopen the saved file and confirm that each attachment is embedded, readable and mapped to the correct question.
Before release, verify the template’s completion status, administrative data, fee/payment evidence where required, signatures and the device configuration. Run a separate scientific review: an electronically complete file can still contain an incorrect classification, unsupported claim or irrelevant test report.
Correctly prepared eSTAR submissions are generally handled through virus scanning and technical screening rather than the conventional refuse-to-accept process. Inaccurate answers and irrelevant or missing evidence can trigger a screening hold. Do not present “eSTAR complete” as acceptance of the scientific case or a guaranteed decision date.
Responding to FDA and planning the next step
For an Additional Information or Technical Screening request, preserve the acknowledged submission’s version and follow the template’s response instructions. Map every FDA question to the revised answer, attachment and supporting rationale. Retain unaffected information and check that a change in one section has not created contradictions elsewhere.
Use our 510(k) submission guide or De Novo guide for the pathway argument, and Pre-Submission guidance when a test strategy needs FDA input before execution. Align the eventual launch with QMSR and registration/listing. Pure Global can review the evidence map, prepare the controlled package and coordinate responses.
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Frequently asked questions
No. eSTAR is the interactive submission template and evidence package. The CDRH Portal is the submission and tracking channel for CDRH. CBER uses its applicable electronic submission channel.
No. FDA currently offers eSTAR voluntarily for supported PMA types and PreSTAR for supported early submissions. Mandatory use applies to covered 510(k) and De Novo submissions and other scope identified by FDA.
No. Completion checks concern the structured package, not the adequacy of the scientific case. Incorrect answers, irrelevant attachments or unsupported claims can still cause screening holds or substantive deficiencies.
FDA generally instructs applicants to update the original acknowledged eSTAR for responses. Follow the request and current response instructions, preserve the controlled submission, and track all changed answers and attachments.
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