The Rise of eSTAR for Medical Device De Novo Submissions

As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource (eSTAR).  The same template can also be used for De Novo submissions.  Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.  On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

Recap of eSTAR

eSTAR is an interactive PDF form designed to assist users in creating a “complete” submission.  It includes questions, text, logic, and prompts, and integrates databases such as FDA product codes and FDA-recognized voluntary consensus standards.  It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents.   For 510(k) and De Novo submissions, FDA’s eSTAR Program website offers two different types of eSTAR templates: Non-In Vitro Diagnostic devices and In Vitro Diagnostic devices.  There is also a third template for Pre-Submissions for Non-In Vitro and In Vitro Diagnostic devices.  Make sure you submit your application using the most up-to-date version of eSTAR, as FDA frequently updates eSTAR templates.  To learn more about our experience with the eSTAR for 510(k)s, check out our previous blogs (here, here).

Structure of the eSTAR for De Novos

The draft guidance provides a table that offers a high-level overview of the structure of the eSTAR for De Novos, including elements such as the cover letter, device description, proposed indications for use, classification, benefits, risks, mitigation measures, labeling, and supporting data.  These content elements precisely follow the De Novo request content described in 21 C.F.R. § 860.220, meaning that using eSTAR does not necessarily change the type and amount of information required in a De Novo submission.

Acceptance Review

eSTAR helps submitters prepare a “complete” 510(k) or De Novo submission.  The Refuse To Accept (RTA) process is an acceptance review of 510(k) submissions, aiming to assess whether a submission is administratively complete, and includes all the necessary information within 15 calendar days of FDA receiving a 510(k) submission.  One key benefit for the industry in using the eSTAR for 510(k)s is that 510(k) eSTAR submissions do not undergo an RTA process.  This is beneficial to industry because at times the RTA review is not purely administrative and crosses into substantive issues.  Note, however, that there is a virus scanning and technical screening process that will still happen.  During the technical review, FDA will check to ensure that the attachments to a question are relevant to the question and there are no inaccurate responses provided to any question.

In contrast, for De Novos, the equivalent of a 510(k) RTA review is an acceptance review of De Novos, codified in 21 C.F.R. § 860.230.  Unlike 510(k)s, using eSTAR for De Novos does not eliminate the acceptance review process, which must be conducted and completed within 15 calendar days of FDA receiving a De Novo request.  The draft guidance notes that “[i]f the eSTAR is not complete when submitted, FDA will notify the submitter via email and identify the incomplete information, and the De Novo will be placed on hold.”  This statement appears consistent with the technical review that is being done for the 510(k) eSTAR submissions.

Timeline

FDA notes that when this draft guidance is finalized, it will specify the corresponding timetable(s) for the implementation of De Novo electronic submissions.  The draft guidance indicates that this timetable will be announced by September 30, 2025.  There will be a transition period before requiring all De Novo requests to be submitted electronically.

We can gain insights into the potential timetable from the FDA’s process for eSTAR for 510(k) submissions.  In September 2021, FDA released a draft guidance on Electronic Submission Template for Medical Device 510(k) Submissions (see our blog).  As of October 1, 2023, approximately two years after the release of that draft guidance, all 510(k) submissions are now required to be submitted using eSTAR.  If FDA follows a similar timeline, it is possible that, in approximately two years, FDA may require that all De Novo submissions must be submitted using eSTAR.  For those with experience in using eSTAR for 510(k) submissions, we anticipate that the learning curve for eSTAR for De Novo submissions may not be as steep when FDA mandates that all De Novo submissions must be submitted using eSTAR.  But, for those who do not have any experience with eSTAR, the learning curve may be more significant.