eSTAR 7.1 Mandatory Use for 510(k) and De Novo Submissions

1. Key takeaways

According to the FDA eSTAR Program page, all 510(k) and De Novo submissions sent to CDRH or CBER — unless exempted — must use the eSTAR template. The current template versions are nIVD eSTAR 7.1 and IVD eSTAR 7.1; the template for early submission requests is PreSTAR 3.1. Version 6.2 was retired on 2026-08-03. These are not advisory defaults but operating conditions for the submission, and they change on published dates that sponsors must track as part of routine project management rather than discover at the moment of filing.

• Mandatory use covers 510(k), De Novo, combination product 510(k)/De Novo submissions to CDRH or CBER, and dual 510(k)/CLIA waiver IVD submissions to CDRH.
• Current versions as verified in October 2026: nIVD eSTAR 7.1, IVD eSTAR 7.1, and PreSTAR 3.1.
• Version 6.2 was retired on 2026-08-03; submissions filed on an outdated version risk being turned away.
• The human factors content guidance, issued 2026-05-29 and effective 2026-08-01, is built into the nIVD and IVD eSTAR templates.

2. Legal basis

The obligation to submit electronically rests in the statute, while the operational requirements — versions, scope, retirement dates — are published and maintained on the FDA eSTAR Program page. The table below lists the instruments cited in the source material.

3. Expert insights

Insight one: the mandatory list and the voluntary list must be kept strictly apart.

Mandatory use applies to 510(k) submissions, De Novo requests, 510(k)/De Novo combination product submissions sent to CDRH or CBER, and dual 510(k)/CLIA waiver IVD submissions sent to CDRH. For this category there is no format choice to make. Voluntary use applies to PMA submissions and their supplement types sent to CDRH or CBER — original PMAs, Panel-Track supplements, Real-Time supplements, 180-day supplements, and 30-day notices / 135-day supplements — as well as Q-Subs, IDEs, and 513(g) requests. Mixing the two lists up in either direction causes planning errors: treating a mandatory case as optional exposes the submission to rejection on format grounds, while assuming every submission is forced onto eSTAR misallocates preparation effort.

Insight two: version retirement dates are hard cut-off points.

According to the FDA page, nIVD eSTAR version 6.2, IVD eSTAR version 6.2, and PreSTAR version 2.2 were all retired on 2026-08-03. Filing on a retired version after its retirement date carries the risk that the submission is turned back. The eSTAR template also distinguishes major from minor versions: a major version update corresponds to significant changes in policy or regulation, such as the step from 1.2 to 2.0, while a minor version update corresponds to other revisions, such as the step from 1.2 to 1.3. Reading the version number therefore tells you how much of your preparation approach may need to change.

Insight three: the human factors content guidance has been folded into the template, with dates attached.

The nIVD and IVD eSTAR templates already contain the substance of the Human Factors Content Guidance, which carries an issue date of 2026-05-29 and an effective date of 2026-08-01. This means human factors engineering material is now a standard section embedded in the template itself, rather than an appendix that each sponsor organizes independently. Preparing that content in an old free-form structure and pasting it in is no longer a sensible workflow.

Insight four: eSTAR is a dynamic PDF, and its handling carries three hard constraints.

According to the FDA page: first, the template cannot be opened directly in a browser; it must be downloaded and opened with Adobe Acrobat Pro, which is recommended, or with PDF Xchange Editor version 10.2.0 or later, or FoxIt PDF Reader version 12.1 or later. Second, on Windows the file must be saved by right-clicking and choosing to save the link as a file. Third, although Adobe Acrobat Reader can open the template, it cannot save changes or add attachments. Teams that discover these constraints on filing day lose time precisely when they have the least of it, so the working environment should be set up and tested well before the submission window opens.

4. Practical recommendations

• Before submitting, check the current version numbers and the retirement dates of older versions on the FDA page.
• Work in a compliant PDF editor — Adobe Acrobat Pro is recommended — and do not rely on a browser or on Acrobat Reader.
• Prepare the human factors engineering section according to the requirements embedded in the template; do not reuse the free-form format of an earlier version.
• Remember that combination product submissions and dual 510(k)/CLIA waiver IVD submissions are equally subject to mandatory eSTAR use.
• Even where use is voluntary — PMA, Q-Sub, IDE, 513(g) — consider standardizing on eSTAR for the sake of content reuse across submissions.

5. Verification checklist

• □ It has been confirmed that this submission falls within the mandatory scope of eSTAR use
• □ The current version has been downloaded and checked (nIVD / IVD eSTAR 7.1, or PreSTAR 3.1)
• □ It has been confirmed that the version in use has not passed its retirement date
• □ A compliant PDF editor such as Adobe Acrobat Pro is being used
• □ The human factors engineering section has been prepared according to the guidance effective 2026-08-01
• □ For a combination product or a dual 510(k)/CLIA waiver IVD, it has been confirmed that eSTAR is likewise required

Regulatory information verified as of October 28, 2026.

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