#estar update

If you are planning a medical device premarket submission for the US market, put two dates on your calendar: August 1 and August 3, 2026. On June 1, 2026 the FDA released one of its most significant updates to the electronic Submission Template and Resource, better known as the FDA eSTAR template. Here is what changed in the eSTAR 7.0 update, why it matters and how to keep your 510(k) electronic submission moving without delays. 

What is eSTAR and where it is used? 

The FDA eSTAR template is an interactive PDF form that walks applicants through every section of a complete medical device submission. Since October 1, 2023 the FDA has required nearly all 510(k) submissions to be filed electronically using eSTAR, in line with its final guidance on electronic submission templates. The mandate also covers De Novo submissions and dual 510(k)/CLIA waiver applications sent to CDRH. 

The upside is real. A properly prepared eSTAR submission is not expected to go through the Refuse to Accept (RTA) process. The catch is that every file still passes virus scanning and technical screening. If a response is inaccurate or an attachment does not match its question, your submission can sit on a technical screening hold for up to 180 days. Getting it right the first time saves serious review time. 

What changed on June 1, 2026

Three updates in the FDA eSTAR update 2026 stand out:

eSTAR Version 7.0 is live. The FDA published updated non-IVD and IVD eSTAR 7.0 templates for 510(k), De Novo and PMA submissions. Both now include the content of the new Human Factors Content Guidance, published on May 29, 2026 and effective from August 1, 2026. If your device has a user interface, expect more structured human factors questions in your next filing.

PreSTAR 3.0 covers more Q-Submissions. The Early Submission Requests eSTAR is now available for voluntary use with Submission Issue Requests, Informational Meetings, Study Risk Determinations, PMA Day 100 Meetings and Accessory Classification Requests, alongside Pre-Submissions, IDEs and 513(g) requests.

A hard retirement date. Important to note that Version 6.2 of both eSTAR templates and PreSTAR 2.2 will be retired on August 3, 2026. The FDA will not reject a retired version outright, but you may receive additional information requests tied to the differences between versions and those requests slow your review.

What you should do now

Download eSTAR 7.0 from the FDA website. Save the file first, then open it in Adobe Acrobat Pro or another supported editor. It will not open in a browser.

Transfer in-progress work using the Export Data and Import Data buttons. Attachments do not carry over, so plan time to reattach them.

Review your human factors and usability documentation against the new guidance before August 1, 2026.

Importantly, if you have already received an FDA acknowledgement letter, stay on your original version. Your submission is grandfathered and responses to Additional Information requests should use that same eSTAR.

Check attachment limits: 1 GB per file and 4 GB per eSTAR through the CDRH Portal. 

How NexorTest can help

At NexorTest, we support medical device manufacturers across the full premarket journey: design verification and validation, EMC/EMI, safety and biocompatibility testing, cybersecurity for SaMD and end-to-end regulatory support covering FDA, EU MDR, CDSCO and ISO 13485 QMS. Our regulatory team prepares and reviews eSTAR-based 510(k) and De Novo submissions, so your file clears technical screening the first time and our local representation across 50+ countries helps you take the same product to global markets. 

Planning a 510(k) electronic submission this year? Talk to our NexorTest regulatory team and start filing your devices with eSTAR 7.0 with confidence.