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

March 1, 2023By Adrienne R. Lenz, Principal Medical Device Regulation Expert

Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s.  The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).  With 18 years’ experience, we have developed a pretty good system for preparing 510(k) submissions in this format.  The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments.  We have made improvements to the content of each of these sections over the years and have included additional information to address other guidance documents and the refuse to accept (RTA) checklist, but the general structure has been constant.  This method of submission development allows for efficient development of each section and collaboration across numerous subject matter experts and internal reviewers.

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here.  The eSTAR templates are interactive PDF forms used to develop and submit 510(k)s (Traditional, Special, or Abbreviated) or De Novo applications, or to submit additional information to these submission types.  There are two forms:  one for non-IVD devices and one for IVD devices.  The same forms are used for both 510(k)s and De Novo submissions.  It appears that use of eSTAR for PMAs may be in the future as it is seen on the templates in the selection for application purpose but is not currently able to be selected.

In order to start learning the format, and also because some submissions can take more than a year for everything to come together and we do not want to switch formats should this occur, we have decided to start some of our newest submissions using the eSTAR non-IVD and IVD templates.  While it may have to do with old dogs learning new tricks, our initial experience suggests that there is a bit of a learning curve and that it might be easier to teach Fido to roll over than it is to figure out a good process for developing 510(k)s in the new format, especially when collaborating with multiple subject matter experts and reviewers, and using cloud-based file sharing.

This post shares some our early learning on how the template works (the good and the bad).  We hope it may be of help to those embarking on an eSTAR submission for the first time.  In a second post, we will cover some of the process challenges that industry may face when using eSTAR.

By way of background, the eSTAR template is a structured form that takes a user section-by-section and question-by-question through the content of the 510(k).  The questions are generally targeted on determining what information needs to be included in the 510(k).  For example, in the Device Description section of the eSTAR template you are asked questions related to, among other things, tissue contact, software/firmware, sterility, device environment, and electrical power.  Based on responses, additional sections, questions, data fields, and places to link files, called attachments, are added.  For example, answering “yes” to the question related to use of software/firmware opens new fields for selecting related technology, including use of cloud communication, network connection, wireless communication, USB/serial ports, and software upgrades.  The selections made here impact the content that will be required later in the section of the templates related to software.

In some sections, there is a field within the template that can be used to enter the requested information or to justify why the information is not needed, or why an alternative approach was used.  In other sections of the template, attachments will be needed to include this type of information.  The text boxes also cannot accommodate tables or figures, which are often helpful particularly in comparing to a predicate device and/or explaining technological features of a device.

While this sounds like a helpful, step-wise process, it is not as easy as it may sound.

Learnings on how eSTAR works

  • Starting Too Early. We all know sponsors are eager to get to clearance and sometimes even start working on their 510(k) submissions while still in development/before the device is finalized.  This could be done with the old format because the sections were fixed at the outset and could be iterated on.  In the eSTAR template, because answers to early questions cause various sections to appear in the template or not (e.g., if a user answers no to a device being sterile, the sterility sections does not present for population), a user may not know answers to all of the questions when they want to start preparing the information and/or they may miss a section depending on how they answer.
  • Know Your Guidances. Several sections of the eSTAR templates have questions that walk through related guidance documents.  For example, the template asks for the number of reprocessing instructions, sterile methods, tissue contact materials, and electronic interfaces and then requests information related to the reprocessing instructions and validation, sterilization validation, biocompatibility, and interoperability in line with relevant guidance documents.  It is important to be familiar with the relevant guidance documents to answer the questions in an appropriate manner.  There are additionally places to provide attachments for test reports and other supporting documents.
  • Performance Testing Summaries No Longer Needed? Maybe.  The required content related to performance testing seems to be a bit light in comparison to other sections.  The RTA checklist for eCopy 510(k) submissions requires a summary of bench performance testing formatted per FDA guidance Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.  In the eSTAR template, the only requirements are a complete test reports for the testing.  This omission is quite surprising given that we have recently seen some RTA deficiencies related to lack of this summary.
  • Performance Testing Comparator versus Predicate. Also, in the performance testing section of  the eSTAR template, the sponsor must identify the 510(k) number for a device “that is the best comparator for the testing.”  We find it interesting that the template calls for a predicate device that may not be the same as the predicate device used to support substantial equivalence.
  • Missing Human Factors. We also note that there is no specific section of the eSTAR templates for human factors documentation to be included. We find this omission somewhat ironic seeing that this template was clearly not prepared using a human factors approach.  We plan to provide the performance test summary and human factors documentation as attachments to the bench performance testing section of the templates.
  • New Labeling Requirements. As we navigate the questions throughout the template, we find that there seem to be some embedded labeling requirements that we have not previously seen.  For example, in the section for EMC, Wireless, Electrical, Mechanical and Thermal Safety there is a requirement to provide testing to support use in an aircraft or a reference to a specific attachment and page where a labeling mitigation that cautions against the use of the device in an aircraft is located.  So even if it is completely obvious that a device would not ever be used in an aircraft, sponsors will need to make sure labeling covers this issue.  Submitters should be sure to review all questions of the template carefully early in development to ensure specific labeling information is incorporated (although not too early in development – see our first point above).
  • Option to Automate the 510(k) Summary. There is an option to provide a 510(k) summary as an attachment or you can enter summary information in fields throughout the template that will be used to auto generate a 510(k) summary.  We will be opting for the attachment as we often use tables or other formatting in 510(k) summaries that are not possible in the eSTAR template fields.
  • Unnecessary Sections Cannot Be Omitted. For submissions of a modification to an existing device, the template requires information for all sections, even if the content of the section is not affected by the change.  In eCopy submissions, a single paragraph could often be used to make statements regarding the nature of the change and explain why new information or testing was not required compared to the previous clearance.  In eSTAR, these statements require repetition in multiple fields and attachments – making it anything but least burdensome.  For example, for a patient contacting device, the number of tissue contacting materials are identified in the template and then, for each material, the contact type and duration are filled in.  The template uses this information to generate tabs for each biocompatibility endpoint that should be evaluated per the relevant guidance.  For a modification to a patient contacting device that does not affect materials or biocompatibility, each tab for each material will require the justification for why that test was not repeated.   The situation is similar for submissions where software is not changing.  The eSTAR template will require a separate attachment for each document type (e.g., SDS, architecture document, software verification and validation) even if the same justification and reference to the prior clearance can be used across all required documents.

But, it is not all doom and gloom when it comes to eSTAR—a few things will remain unchanged (thank goodness!). First, in the eSTAR template, the sections for the Device Description, Substantial Equivalence, and Executive Summary require attachments.  This means the attachments can be formatted and organized in whatever way the sponsor prefers.  Based on our work to date, we have needed to make only a few updates to the format we used for eCopy submissions.  Given that these are some of the most critical sections in the 510(k), it is a great relief to know their structure and organization can largely remain the same.

Second, there is an option to continue to submit responses to additional information (AI) requests in an eCopy format. The eSTAR templates can also be used to respond to requests for additional information.  When entering the template, the user can select “additional information” as the submission type.  When doing so, a pop-up window provides two options.  The options are (1) to provide responses and attachments as an eCopy without an updated eSTAR template, or (2) to provide an updated eSTAR template (using the same version used for the original submission).  In this case, a section of the eSTAR template will be completed by copying the deficiency into one field and providing the response in another field.  New attachments are then included in the relevant section of the eSTAR template itself.  Depending on the nature of the deficiency, the fields in the template may not be sufficient for providing lengthy explanations that require tables, figures, or formatting to keep the response clear and organized so we are glad the eCopy option will still be available.  As anyone who has ever worked on a lengthy and/or complicated AI response knows, these responses do not always fit neatly in a text box.

Transitioning to the eSTAR template will taking some getting used to.  In both the form, as discussed above, and in process—which we will cover in Part 2 of our post.