Electronic Submission Template for Medical Device 510(k) Submissions

Nearly one year after FDA published a draft guidance on its Electronic Submission Template for Medical Device Submissions (see our blog post here), the Agency is back to formally introduce the widespread implementation of the electronic Submission Template And Resource (eSTAR) electronic submission template for 510(k) submissions. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. add-to-files).

As its name implies, eSTAR is intended to be a guided submission preparation tool for industry (see here for the FDA’s website for eSTAR). It is designed to improve consistency and enhance efficiency in the review process with data and content that are captured in fields, dropdown boxes, checkboxes, etc. that align with the content of the SMART 510(k) review memo template used by CDRH reviewers (see here for the details of the SMART memo template).

The development of an electronic submission template for 510(k) submissions is significant in that:

1. eSTAR submissions are not expected to go through the refuse to accept (RTA) process. Instead, it will go through a virus scanning and technical screening process to verify that eSTAR responses accurately describe the device and there is at least one applicable attachment per relevant attachment-type question. Although this screening is anticipated to occur within 15 days (the same time as the RTA process), given the electronic nature, we hope this means a shorter administrative turnaround time compared to the RTA process. (A submitter has 180 days to submit a replacement eSTAR upon receipt of a technical screening deficiency notification; failure to do so will result in the 510(k) being withdrawn just like the RTA process.)
2. eSTAR submissions are automated (e.g., form construction, auto filling). eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. This is a welcome benefit as failure to include these items can result in an RTA designation, stop the review clock, and require time and attention to address with the traditional eCopy submission method. Even if it did not result in an RTA designation, time spent chasing down purportedly missing items (when they were included) could be better spent on substantive review.
3. eSTAR employs targeted questions to collect specific data and information and includes applicable links to regulations, relevant guidance documents, and other resources. (For additional information on the structure and referenced guidance documents, please refer to Table 1 of the Electronic Submission Template for Medical Device 510(k) Submissions guidance document.) This has the potential to make the FDA’s review efficient as relevant information is collected upfront.
4. eSTAR uses the widely available Adobe Acrobat Pro and is compatible with mobile devices for certain PDF features. In response to feedback from users of eSubmitter (software that contained electronic submission templates, including one for preparing a 510(k) submission, and was available from September 2018 through May 2021), eSTAR allows comments to be added to the submission PDF for the purposes of preparing a submission. Comments could include reminders to fill in specific data or call attention to a section of the submission that requires additional review. This is helpful especially when collaborating with teammates on the review and revision process. Users will see a pop-up window appear during the flattening process (i.e., printing to PDF) that states comments will not be sent to FDA.
5. eSTAR allows for responses to additional information (AI) requests. eSTAR guides the submitter in modifying the original submission so that the requests can be addressed. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps. This development is noteworthy because it aids reviewers in easily identifying where and how submitters have addressed each of FDA’s AI requests. This could, however, become limiting for more complex or innovative device submissions where various elements are connected and/or information needs to be contextualized.

With the exception of points 1 and 5 above, these are not different from when the draft guidance came out in September 2021. However, they are worth reiterating for their potential downstream effect.

On October 3, 2022, FDA announced that eSTAR and eCopy submissions can be submitted through the CDRH Customer Collaboration Portal (CDRH Portal). This builds on the progress tracker launched in 2021 for 510(k) submissions and allows anyone to register for a CDRH Portal account to send their eSTAR and eCopy submissions.

Exemptions from the electronic submission requirements apply to interactive review responses and some amendments (e.g., appeals, substantive summary requests, change in correspondent, and amendments after final decision). FDA does not intend to grant waiver requests. In the meantime, use of eSTAR is voluntary and may be good practice to ensure familiarity with the template before the practice becomes official.  With limited experience using eSTAR, to date, while it seems promising and certainly streamlined for FDA, it is possible there could be drawbacks to users once widespread adoption begins.  We look forward to using the new format and will certainly report back to our readers with both the good and bad.