US FDA Status of eSTAR: eSTAR Version 5.5 Released

By Sarah Fitzgerald and Evangeline Loh

Background on eSTAR

The electronic submission template and resource (eSTAR) template can be used to submit US FDA Premarket Notifications (510(k)s), De Novos, and Traditional Premarket Applications (PMAs). eSTAR was compulsory for 510(k) submissions starting in October 2023. eSTAR will be required for De Novos starting in October 2025.

eSTAR version 5.5

eSTAR Version 5.5 was released (February 12). The revision from Version 5.4 to Version 5.5 represents a minor change. The US FDA provides notes on the changes included in this revision. In general, the FDA accepts the use of an older eSTAR version that is a minor change but requires the use of a new major revision within a specified period.

The most fascinating update to us is that the Indications for Use section includes the eSTAR model rather than the format from Form 3881. The FDA explains that this is to prepare to include “additional jurisdictions”.

There are also updates to prevent unaccepted attachment types from being attached, expanded text boxes to facilitate printing as a flat pdf, a bug fix and help text from published guidance on Predetermined Change Control Plans (PCCP) added.

Concluding remarks

The MedTech industry has begun to collect experience with eSTAR. It has been compulsory for 510(k)s for over one year and will become mandatory for De Novos in about six months.

It is not always apparent from the FDA website that there has been a minor revision to the eSTAR, as only the major version number is indicated on the site. However, when one accesses the eSTAR template, the full version number is clear.

eSTAR Version 5.5 is of interest to us as it suggests there is progress with the use of eSTAR within the IMDRF Regulated Product Submission Working Group.