The eSTAR is FDA's interactive PDF template for device submissions, required for 510(k)s since October 1, 2023, and for De Novo requests since October 1, 2025. Its current version for both, 7.1, came out on September 21, 2026, and FDA can hold an eSTAR when an answer is inaccurate or none of a question's attachments is relevant.
Key takeaways
- eSTAR has been required for 510(k)s since October 1, 2023, and for De Novo requests since October 1, 2025. It is voluntary for PMAs, Q-Submissions, IDEs and 513(g) requests.
- The latest major version, eSTAR 7.0, was released on June 1, 2026, and added a Human Factors subsection to Performance Testing.
- We ran through the nIVD template's own version history: FDA has released 13 eSTAR updates since eSTAR became mandatory for 510(k)s, including three major versions.
- FDA can place an eSTAR on hold when an answer is inaccurate, or when none of the attachments to a question is relevant to it.
- The CDRH Portal accepts attachments up to 1 GB and an eSTAR up to 4 GB, and eSTAR rejects attachment names longer than 124 characters.
What is the FDA eSTAR template?
eSTAR, the electronic Submission Template and Resource, is an interactive PDF form that guides you through preparing a device submission [1]. It gives FDA reviewers a standard structure, and it shows only the questions that apply to your device, based on your earlier answers [1]. Our eSTAR overview summarizes the program.
Which submissions must use eSTAR? FDA sets out mandatory and voluntary uses [1, 5]:
| Submission | eSTAR use |
|---|---|
| 510(k), including Traditional, Special and Abbreviated | Required since October 1, 2023, unless exempted [2] |
| De Novo request | Required since October 1, 2025, unless exempted [3, 5] |
| Dual 510(k) and CLIA waiver submission for an in vitro diagnostic, sent to CDRH | Required [1] |
| 510(k) or De Novo for a combination product sent to CDRH or CBER | Required [1] |
| PMA and several PMA supplement types | Voluntary [1] |
| Q-Submission, IDE and 513(g) request | Voluntary, using the PreSTAR template [1] |
For 510(k)s, the exemptions cover follow-up items, such as certain amendments and withdrawal requests, not original submissions [2]. FDA says it does not intend to grant waivers [2].
There are three templates. The nIVD eSTAR covers non-in vitro diagnostic devices, the IVD eSTAR covers in vitro diagnostics, and the PreSTAR covers early requests such as Q-Submissions [1]. As of September 26, 2026, the current versions are nIVD eSTAR 7.1, IVD eSTAR 7.1 and PreSTAR 3.1 [1].
Download it before you open it. eSTAR cannot be opened in a web browser. On Windows, right-click the link and choose "Save Link As". On a Mac, Control-click the link and choose "Download Linked File" [1]. Then open it in Adobe Acrobat Pro, which FDA recommends, PDF-XChange Editor 10.2.0 or higher, or Foxit PDF Reader 12.1 or higher [1]. Adobe Acrobat Reader opens eSTAR, but cannot save changes or add attachments [1].
Which eSTAR version should you use?
Use the current major version. If you submit on an older major version, you may receive additional information requests about what changed, especially if the changes apply to your device type [1]. Minor version gaps do not usually cause such requests [1].
FDA removes old versions. When an eSTAR update reflects a policy or regulatory change, FDA releases it before the change takes effect and removes the previous version on the implementation date [4].
We ran a count of the version history inside the current nIVD eSTAR [4]. FDA has released 30 versions since January 7, 2019, including seven major versions:
| Major version | Released |
|---|---|
| 1.0 | November 29, 2021 |
| 2.0 | June 6, 2022 |
| 3.0 | March 29, 2023 |
| 4.0 | June 12, 2023 |
| 5.0 | December 6, 2023 |
| 6.0 | October 1, 2025 |
| 7.0 | June 1, 2026 |
Source: version history in FDA's nIVD eSTAR Version 7.1, downloaded September 26, 2026 [4].
FDA released three eSTAR updates in 2025 (5.5, 5.6 and 6.0), and four so far in 2026 (6.1, 6.2, 7.0 and 7.1) [4]. If your project runs for several months, the template may change before you submit.
What changed recently:
- 7.0 (June 1, 2026): added a Human Factors subsection to Performance Testing, consistent with FDA's new human factors content guidance [4, 9]. It also let you insert standards and responses and change their order [4].
- 7.1 (September 21, 2026): added checks to improve the accuracy of administrative data, removed the optional Intended Population question, clarified human factors for Special 510(k)s, and made several EMC changes [4]. FDA notes that previous versions may still be used with the new login process [4].
- 6.0 (October 1, 2025): reflected the required use of eSTAR for De Novo requests, and added a button that deletes all earlier deficiency responses when you answer a second additional information request [4].
- 5.6 (July 10, 2025): added an alternative Cybersecurity workflow with fewer questions, to reflect FDA's updated cybersecurity guidance [4]. Our FDA cybersecurity guide covers FDA's cybersecurity requirements in more depth.
If your device has a user interface, check the Human Factors subsection in version 7.x. Our human factors testing guide explains what goes in it.
Your version is locked once FDA acknowledges it. After FDA sends the acknowledgment letter, your submission is tied to that eSTAR version [1]. When you respond to a hold or additional information request, update your original eSTAR rather than switching to a newer one [1].
What sections does the eSTAR contain?
FDA's eSTAR guidance lists these sections for a 510(k), in order [2]:
- Submission type, cover letter and applicant information
- Pre-Submission correspondence and previous regulator interaction
- Consensus standards
- Device description
- Proposed indications for use
- Classification
- Predicates and substantial equivalence
- Design and special controls, risks to health and mitigation measures
- Labeling
- Reprocessing, sterility and shelf life
- Biocompatibility
- Software and firmware
- Cybersecurity and interoperability
- EMC, electrical, mechanical, wireless and thermal safety
- Performance testing
- References and administrative documentation
- Additional information response
This list reflects the template when FDA issued the guidance on October 2, 2023 [2]. Later versions have added subsections, such as Human Factors in version 7.0 [4].
eSTAR asks for documents as you go. If you indicate that clinical testing supports your submission, for example, eSTAR prompts for the clinical documents and any financial certifications or disclosures [2].
Some forms are built in. The Indications for Use form (FDA 3881), the Premarket Review Submission Cover Sheet (FDA 3514) and any Declaration of Conformity are part of eSTAR, so you do not attach them separately [1]. If you create your 510(k) Summary in eSTAR, you do not need a separate one, and you can edit the generated summary [1].
Standards come from a list. FDA-recognized standards appear in the Standards section drop-down [1]. You can type in a standard FDA has not recognized; its recognition number field stays blank [1].
Which mistakes trigger an eSTAR hold?
FDA names the failures that trigger a technical screening hold, and warns about others that can stop or slow your submission. FDA anticipates finishing technical screening within 15 days of receiving your eSTAR [2]. We found no FDA ranking of how often each failure occurs. So far in fiscal year 2026, 8.67% of 510(k)s that completed a first screening failed it [6].
Mistakes that can trigger a hold:
- An inaccurate answer. FDA verifies that your answers describe the device. Its example: stating that the device has no tissue-contacting components when it has some [2].
- A drop-down answer that hides questions. An inaccurate drop-down answer can make eSTAR skip questions that should appear, and FDA says that may lead to an early hold [1].
- An irrelevant attachment. FDA can place an eSTAR on hold when none of the attachments to a question are relevant to it [1].
- The wrong 510(k) type. If a Special 510(k) should have been a Traditional 510(k), for example, FDA places it on hold until the correct type arrives [7].
Mistakes that stop you submitting:
- An incomplete eSTAR. The CDRH Portal does not accept an eSTAR whose status still reads "eSTAR INCOMPLETE" [1].
- Files that are too large. Through the CDRH Portal, each attachment can be up to 1 GB and the whole eSTAR up to 4 GB [1]. Larger submissions go by post, following the Portal's instructions [1].
- Long file names. eSTAR does not accept attachment names longer than 124 characters [1].
- Unaccepted file types. eSTAR automatically rejects zip files [1].
Mistakes that cost you time:
- Attaching from a shared drive. FDA says this can leave a document unattached or corrupted, so keep attachments on a local drive [1].
- Editing after signing. Once the Truthful and Accurate Statement is signed, you cannot add or delete attachments until the signature is cleared, and only the signer can clear it [1].
- Editing at the same time. eSTAR does not support co-authoring. Only one person can edit it at a time, though you can store it in SharePoint or Box [1].
- Using Adobe Acrobat Reader. It cannot save your work or add attachments [1].
- Password-protected PDFs. FDA discourages them, because they slow its redaction of confidential information [1].
Our FDA RTA checklist covers what FDA screens for in its first 15 days. Complizen's Submission Builder drafts your submission and exports it as an eSTAR, with pre-flight checks against FDA's Refuse to Accept criteria.
How do you respond to a hold in eSTAR?
Modify your original eSTAR. Choose Additional Information under Application Sub-Type, and an Additional Information Response section appears at the end of the form [1].
- Copy each FDA question into the response section and answer it below [1].
- Use the "Add Response" button for each further question [1].
- Add new attachments to the sections affected by the deficiencies [1].
- Leave unaffected sections and their attachments unchanged [1].
Put tables in attachments. You cannot insert tables or graphs into eSTAR text boxes, so attach them in the right section and refer to them in your response [1].
Watch the deadline. For a technical screening hold, FDA considers the 510(k) withdrawn if it does not receive a complete replacement eSTAR within 180 days [2, 8]. Our guide to FDA additional information requests covers requests that come later, during substantive review.
What else should international teams know?
Write in English. FDA's acceptance checklist asks for all supporting content in English, including translations of test reports and literature articles [10].
Submit before 4 PM Eastern Time. The CDRH Portal processes submissions received before 4 PM Eastern Time on a US business day the same day, and later ones on the next business day [5].
Number attachments the IMDRF way. FDA has no required file naming, but recommends the internationally harmonized IMDRF numbering, such as "1.01 Cover Letter.pdf" [1]. The number shows when you hover over each attachment question [1].
Move data between versions with XML. In Adobe Acrobat Pro, the Export Data and Import Data buttons move your answers into a newer eSTAR [1]. Attachments are not carried over, so add them again [1].
Send most documents inside eSTAR. FDA strongly discourages sending documents outside the eSTAR [1]. The exceptions include statistical CDISC files, DICOM files and large media files, which go as an additional data package through the CDRH Portal [1].
Know who to contact. For template malfunctions, FDA asks you to email [email protected] [1]. For questions about a 510(k) or De Novo request, it lists [email protected] [1].
Not sure whether you need a consultant for an eSTAR 510(k)? See what you can file yourself.
Frequently asked questions
Is eSTAR required for a 510(k)?
Yes. Since October 1, 2023, a 510(k) must be submitted as an eSTAR unless an exemption applies, and the exemptions cover follow-up items, not original 510(k)s. FDA says it does not intend to grant waivers. De Novo requests have also required eSTAR since October 1, 2025.
What is the current version of eSTAR?
As of September 26, 2026, FDA's current templates are nIVD eSTAR 7.1 and IVD eSTAR 7.1, released on September 21, 2026, and PreSTAR 3.1 for early requests. The latest major version, 7.0, was released on June 1, 2026. The nIVD template's version history shows five updates between October 1, 2025 and September 21, 2026.
Do I have to use the latest eSTAR version?
Not always. FDA says an older minor version usually does not cause additional information requests, but an older major version may, if the changes apply to your device. Once FDA acknowledges your submission, you keep that version for your responses.
Why won't the eSTAR open when I click the link?
eSTAR cannot open in a web browser. Save the file first: right-click the link and choose "Save Link As" on Windows, or Control-click and choose "Download Linked File" on a Mac. Then open it in Adobe Acrobat Pro, PDF-XChange Editor or Foxit PDF Reader.
Can I use Adobe Acrobat Reader for eSTAR?
Adobe Acrobat Reader opens eSTAR, but it cannot save your changes or add attachments. FDA recommends Adobe Acrobat Pro, and also lists PDF-XChange Editor version 10.2.0 or higher and Foxit PDF Reader version 12.1 or higher as options. Since version 5.0, eSTAR shows a popup message if you open it in Adobe Acrobat Reader.
What is the file size limit for eSTAR?
Through the CDRH Portal, each attachment can be up to 1 GB and the whole eSTAR up to 4 GB. Larger submissions are sent by post, following the CDRH Portal's instructions. Submissions to CBER through FDA's Electronic Submission Gateway can be up to 100 GB.
Why did my eSTAR go on technical screening hold?
FDA places an eSTAR on hold when an answer is inaccurate, or when none of the attachments to a question is relevant to it. An inaccurate drop-down answer that hides later questions can also lead to an early hold. FDA's hold notice identifies the incomplete information.
How do I respond to a technical screening hold?
Modify your original eSTAR and choose Additional Information under Application Sub-Type. Copy each FDA question into the response section, answer it, and add new attachments to the affected sections. Leave sections not affected by the deficiencies unchanged. You have 180 days to send a complete replacement eSTAR.
Can several people work on the same eSTAR?
Yes, but not at the same time. eSTAR does not support co-authoring, so only one person can edit it at a time. You can store it in SharePoint or Box, and print a static copy for colleagues to review and comment on.
Why can't I add or delete attachments in my eSTAR?
If eSTAR says the signed copy cannot be changed, it has been signed. After an electronic signature, such as in the Truthful and Accurate Statement, you must clear the signature before changing attachments. Only the person who signed can clear it, using Clear Signature in Adobe Acrobat Pro.
Can I move my data to a newer eSTAR version?
Yes. In Adobe Acrobat Pro, use Export Data in your old eSTAR to save an XML file, then Import Data in the new eSTAR. Attachments are not included in the XML file, so you need to add them again. Do this before FDA acknowledges your submission; after that, respond in your original version.
Can I submit a bundled 510(k) in eSTAR?
Yes. Choose a primary product code in the Classification section, reflecting the devices' primary purpose, and list the other product codes in the Associated Product Codes field. The help text for the Indications for Use field explains how to divide the indications by device.
References
- FDA. eSTAR Program. Content current as of September 21, 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Guidance issued October 2, 2023.
- FDA. Electronic Submission Template for Medical Device De Novo Requests. Guidance issued August 23, 2024.
- FDA. Non-In Vitro Diagnostic (nIVD) eSTAR Version 7.1, version history. Released September 21, 2026; downloaded September 26, 2026.
- FDA. Send and Track Medical Device Premarket Submissions Online: CDRH Portal. Content current as of December 5, 2025.
- FDA. MDUFA V Performance Report, for the quarterly meeting of August 25, 2026, Table 6.1. Data through June 30, 2026.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Guidance issued October 3, 2022.
- FDA. 510(k) Submission Process. Content current as of October 3, 2022.
- FDA. Content of Human Factors Information in Medical Device Marketing Submissions. Guidance issued May 29, 2026.
- FDA. Refuse to Accept Policy for 510(k)s, acceptance checklists. Guidance issued April 21, 2022.