On December 6, 2023, FDA marked a milestone by updating its eSTAR templates for In Vitro Diagnostic (IVD) and non-In Vitro Diagnostic (n-IVD) medical devices, the seventh update within this year.
The updated eSTAR templates now facilitate the submission of various PMA submission types to FDA, including Original, Panel-Track, 180-Day, and Real Time Submissions. However, it’s important to note that Modular PMAs are currently not encompassed within the scope of eSTAR.
At present, utilizing eSTAR for PMA submissions remains voluntary. However, drawing from the trajectory observed with 510(k) submissions, it’s foreseeable that eSTAR integration will eventually become mandatory for PMA submissions as well. For 510(k) submissions, the eSTAR template final guidance was issued in 2022, mandating their use for 510(k)s in October 2023, one year later. A similar implementation window of one year is foreseeable upon the publication of final guidance for PMA submissions.
It’s important to proactively review the eSTAR templates ahead of their mandatory implementation, and reassess previously-submitted PMAs to evaluate their compatibility.
Should any adjustments be required to align the PMA eSTAR template with your device type, be sure to communicate with FDA in a timely fashion. The eSTAR templates are undergoing continual refinement, so there are opportunities for necessary adjustments as long as you communicate proactively with the agency.
Aside from the inclusion of PMA sections, the latest iteration of eSTAR brings noteworthy updates to sections such as cybersecurity, electromagnetic compatibility , and sterility. Further information about those updates can be found in the version history section of the templates.
Given the substantial modifications introduced in Version 5, the medtech industry must prepare for this transition before initiating new applications. Using older versions of the eSTAR templates in a new 510(k) submission might prompt additional inquiries from the FDA during the submission process, potentially leading to avoidable delays.
To learn more about how your organization can prepare for eSTAR, watch this joint webinar with FDA eSTAR creator, Patrick Axtell.