US FDA Updates to eSTAR (version 7.0) and preSTAR (version 3.0)

By Stuart Goldman and Sarah Fitzgerald

Background

The U.S. Food and Drug Administration (FDA) provides templates for many of the types of submissions made before the marketing submission (such as Q-submissions) using their PreSTAR template and for the marketing submission (such as a 510(k)) using their eSTAR templates (one intended for in vitro diagnostic devices [IVDs] and the other intended for all other medical devices). Certain submissions, specifically 510(k)s and De Novo submissions, are required to use these templates unless a specific exemption is provided. 

Updated versions

On June 1, 2026, the FDA released new major version for both eSTAR templates (version 7.0) and the PreSTAR template (version 3.0). These are major revisions to the templates meaning that after a transition period, the FDA expects all new submissions to be made using these versions of the templates. The transition date given is August 3, 2026. For responses made to the FDA, the original version used can still be used. 

eSTAR version 7.0

eSTAR submissions are required for the submission of 510(k)s and de novos. They may also be used for premarket applications (PMAs). On their website, the FDA specifically notes that the eSTAR templates now include content related to their updated Human Factors Guidance. In the version history in eSTAR itself (non-IVD version), the FDA also notes that there is now an ability to adjust the order of standards and additional information responses within the submission and that facility information for PMAs has been updated for the addition of new facilities in a PMA supplement. Additionally, they note that a known issue / bug has been fixed. 

Reviewing the template, the update related to human factors presents as a new section within the Performance Testing section of eSTAR for Human Factors and Usability. This includes a drop-down menu indicating if this includes HF Submission Category 1, 2, or 3 or “Guide Me.” If Guide Me is selected, eSTAR provides questions to answer in order to reach one of the categories. If one of the categories is selected, boxes in which to add information are provided in alignment with the updated FDA guidance. 

PreSTAR Version 3.0

PreSTAR submissions are currently voluntary. The previous version was available for use for 513(g) requests for classification, pre-submission Q-submission meetings (pre-subs), and investigational device exemptions (IDEs). On their website, the FDA specifically notes that the PreSTAR template now is available for use for additional Q-submissions, specifically submission issue requests, informational meeting, study risk determinations, PMA day 100 meetings, and accessory classification requests. For each of these new meeting types, structure has been placed around the requirements to provide a functioning template. In the version history in PreSTAR itself, the FDA also notes that there is now the ability to adjust the order of standards, additional information responses, and questions within the submission and that there have been some minor updates in wording for clarity. Additionally, they note that multiple known issues / bugs have been fixed. 

Reviewing the templates for pre-subs, we did not note any other updates. 

Concluding remarks

The FDA continues to update and refine their eSTAR and PreSTAR templates. Using these templates is mandatory for 510(k) and de novo submissions and optional for a variety of other submissions. 

If a manufacturer has already started to compile a submission within the 6.X version of eSTAR or the 2.X version of PreSTAR and intends to submit this by August 3, 2026, no specific action is necessary at this time. However, if there is a delay in the submission, the company should seriously consider transferring the information to the new template version. 

If a company has not yet started to compile a submission, the new template version should be used. 

Last, Emergo by UL experts continue to monitor developments with the Health Canada pilot of eSTAR as well as the IMDRF RPS WG commitment to adopting eSTAR.