The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s: Part 2

March 8, 2023By Adrienne R. Lenz, Principal Medical Device Regulation Expert

As we discussed in our prior post, the electronic Submission Template And Resource (eSTAR) template will take getting used to in terms of form.  It is also going to take some getting used to in terms of process.  As most in the device industry know, preparing a 510(k) is typically a collaborative process—with multiple functions, consultants, and levels of management often involved in its review and creation.

Based on our early experience using the eSTAR template, we discuss some of the challenges in preparing a 510(k) using the eSTAR template as compared to the traditional format.

  • Restricted collaboration and inability to track changes. Collaboration and development with iterative reviews and revisions are the biggest challenges we have identified with the eSTAR templates.  The templates do not allow for changes to be tracked by author or the ability to add and reply to comments within the template itself.  These are both features that we use frequently in developing submission content interactively.  The templates allow a version to be saved that allows comments but requires that any changes made in response to the comments be made in the primary version to the file.  If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated.
  • Lack of compatibility with cloud-based document sharing. Many teams use cloud-based file sharing systems to work collaboratively on files.  Unfortunately, we have found that the eSTAR template PDF file does not work on these platforms.  It must first be downloaded, revised, and uploaded back to the system.  As above, if multiple people are reviewing simultaneously, and without an easy way to see revisions from each team member, it can be more challenging to ensure all revisions are incorporated.
  • Creation of unnecessary documents. For each section that requires an attachment, you must include a file.  There is no option to reference a document that has already been attached elsewhere in the submission.  This may result in the need to create additional documents that you may not necessarily need under the quality system.  One example is a requirement to provide “an attachment that addresses the risks associated with exposure to specific common EM emitters that are not adequately addressed by IEC 60601-1-2.”  This information may be in a system risk analysis that may have been provided as an attachment in the device description or software section versus a standalone document.  Instead of allowing a reference to the location in another attachment where the information is covered, a separate document must be attached.

It is unclear how FDA will handle changes to the template.  For the last 18 years, the 20-section format has been consistent and reliable, although there have been occasional surprises when the refuse to accept (RTA) checklist has been quietly revised.  Sponsors often start working on 510(k)s long before they are filed.  Therefore, we hope that changes to the eSTAR templates are not frequent and that there is ample transition time to use an existing version that a submission was started with when a new version is released.  Overall, we are planning additional time and hope that with a few eSTAR submission under our belts, they will become more easily managed.

For those new to 510(k) submissions or who submit 510(k)s infrequently, having all the necessary content outlined in a single file may be a little less overwhelming compared to the existing process.  Use of the eSTAR templates may decrease the risk that a 510(k)-naïve user submits a 510(k) lacking important information expected by the Agency.  However, not providing the appropriate type of information and level of detail the Agency expects is still possible with eSTAR.  This is especially true for information specific to the device type.  To this end, we doubt there will be fewer requests for additional information for 510(k)s prepared using the eSTAR templates.

FDA has stated that the template aligns with the reviewer templates used within the Agency.  Given the challenges that using the eSTAR template will present to industry, we hope this alignment means we may see some efficiency in FDA review times to balance out the increased time needed for preparation.