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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

eSTAR

FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types

MedDevice Startups Staff · 2 days ago · 2 min read · Via FDA eSTAR Program

FDA updated the eSTAR templates on September 21. The non-IVD and IVD versions, both at 7.1, now carry the content of the human factors guidance FDA published on May 29 and made effective August 1.

PreSTAR moved to version 3.1 in the same update. It now covers Submission Issue Requests, Informational Meetings, Study Risk Determinations, PMA Day 100 Meetings and Accessory Classification Requests. The template previously handled a narrower slice of the Q-Submission program alongside IDEs and 513(g) requests.

The practical effect lands on small teams. Human factors questions now sit inline in the template, so a company that never did a use-related risk analysis finds that out while filling in the form rather than in a hold letter 15 days after submission.

Questions & Answers

What changed in the FDA eSTAR update on September 21, 2026?

FDA added the content of its human factors guidance to both the non-IVD and IVD eSTAR templates, now at version 7.1. The agency also moved PreSTAR to version 3.1 and widened the Q-Submission types it covers.

Which Q-Submission types does PreSTAR 3.1 now support?

PreSTAR 3.1 adds Submission Issue Requests, Informational Meetings, Study Risk Determinations, PMA Day 100 Meetings and Accessory Classification Requests. It already handled Q-Submissions, IDEs and 513(g) requests.

When did the FDA human factors guidance take effect?

FDA published the human factors content guidance on May 29, 2026, and it took effect on August 1, 2026. As of the September 21, 2026 eSTAR update, its content is built into the submission templates.

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