In 2020, the FDA launched the new eSTAR pilot program. eSTAR is a PDF eSubmission that is an alternative to the eSubmitter software that the FDA has been developing over the years, and an alternative to the current FDA eCopy that is the primary method companies use to prepare a 510(k) premarket notification. The eSTAR template was created by reviewers and is actually easy to use (if you understand the basics of preparing a 510(k) in the first place).

The implementation plan for eSTAR was set back by the Covid19 pandemic, but the FDA is accepting eSTAR submissions for 510(k) premarket notifications. This video provides an introduction to the templates and explains how Medical Device Academy is adapting its normal 510(k) workflow to use the templates. The templates are designed to ensure that the submitter includes everything that is required for a 510(k) submission and eliminates the need for RTA screening by the FDA. The process also eliminates the need to format 510(k) submissions for an FDA eCopy. We are able to use all of our existing templates for a 510(k) submission, the need for some of the templates is eliminated, and only our 510(k) cover letter template was modified specifically for use with eSTAR submissions.

Particular highlights associated with the eSTAR template include: 1) builtin workflows for creating a summary of the testing provided for sterilization validation and biocompatibility and sterilization, 2) a builtin checklist for software and firmware verification and validation documentation, 3) hyperlinks to the most recent FDA guidance documents for each section of the 510(k) submission, 4) the ability to attach nonPDF files up to 1GB in size; and 5) automatic verification that each section of the 510(k) is complete.

The FDA has not released formal guidance to accompany the eSTAR templates, but help features embedded into the template largely eliminate the need for instructions or guidance. One of the most interesting observations we had was related to the three big yellow caution statements which warn the user not to enter confidential information into the PDF form. It appears that there is the potential for FOIA requests to be fulfilled in a semiautomated way by exporting the XML content of an eSTAR submission. The attachments are not exported. Therefore, an FOI could consist of the content provided by the XML export rather than manually creating a redacted 510(k) submission of much larger file size (no more 2year waits for an FOIA?).

If you have any personal experience with eSTAR submissions, questions, or related updates, please comment on our video below.