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.
US FDA Status of eSTAR: eSTAR Version 5.5 Released | Emergo by UL
US FDA Status of eSTAR: eSTAR Version 5.5 Released
Here’s what medical device manufacturers need to know about the electronic submission template and resource (eSTAR) that will be required for De Novos starting in October 2025.
www.emergobyul.com