With the date for use of eSTAR for all 510(k) submissions fast approaching on October 1 2023, I decided it was time for me to try it out and make sure the process for compiling 510(k)s at Kapstone remained efficient.

For those who are not familiar with eSTAR, it is an interactive PDF template created by the FDA to guide applicants through the preparation of submissions, with templates already available for Non-In Vitro Diagnostic (nIVD) 510(k) and De Novo applications, In Vitro Diagnostic (IVD) 510(k), and De Novo applications, and most recently for pre-submissions. The templates all follow the existing guidance documents out there that discuss the correct format and contents for the various eligible submissions. As you make your selections within the interactive PDF, certain sections of the PDF become visible or enabled while others are disabled.

The current eSTAR template allows for Traditional 510(k)s, Abbreviated (510(k)s, Special 510(k)s, and De Novo submissions. Currently disabled are options for a Premarket Approval Submission and Health Canada submissions, so we know this is coming. In fact, the U.S. FDA is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot with the intent of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal.

Throughout the PDF, there are opportunities for direct inputting of information to allow an automatic 510(k) summary to be created, including text boxes for a device description summary, a substantial equivalence comparison, and performance testing. If you choose to use the 510(k) summary produced automatically at the end of the template (in the Administrative Documentation page), the information provided in the sections above must include the requirements in 21 CFR 807.92. As is performed with current 510(k) summaries, the contents of the automated 510(k) Summary will be made publicly available on the FDA website if your device is cleared.  In each section, there are buttons to allow for attachments within each section, if applicable. The contents of the eSTAR submission can be exported in XML format and can be imported into another template, and the single PDF containing all data and attachments is submitted through the CDRH portal. As you work through the template, each section has a color bar in the left column denoting whether the section is complete, incomplete, or not mandatory to be completed.

The FDA has just released a Version 4 template for the nIVD and IVD templates, with Version 3 eSTAR to be retired on August 13, 2023. The change I noticed was additional interactive options within the biocompatibility tabs, but the formal communication of the change included updates in the software section according to FDA Software Guidance document, a fixed bug in EMC section where if a user indicated no recognized standard was used and then chose a risk categorization above this question, content would display inadvertently, and an added textbox for describing unsolicited Additional Information in Additional Information section. In addition, a new 1 GB attachment size limit was added to accommodate CDRH Portal restriction.

Although I haven’t used the template as of yet, the new PreSTAR template follows the same style and functionality as the eSTAR template. You can only select Pre-sub request for feedback or request for meeting at this time, with all other Q-sub types greyed out.

The template follows the pre-submission format described in the FDA Q-Submission Guidance document, however it appears that there is a limit on the breadth of the scope of the pre-submission as you have to select up to a maximum of four (4) topic categories that are applicable to this submission (there are a total of 21 options ranging from biocompatibility to labeling to human factors). The PDF contains sections for product Description, indications for use, classification, labeling, and pre-submission questions. The pre-submission questions are limited to the 4 categories selected earlier, with a maximum of ten (10) questions allowed, with the following message “If you would like to submit more questions, please consider submitting another Pre-Sub. Due to resource constraints, submitting separate Pre-Subs will support the facilitation of more productive meetings, and allow for more effective feedback.” At this time the PreSTAR template is in a beta version, so there is no current date stated when submissions using PreSTAR template will be mandatory.

Now that you (hopefully) have a better understanding of the eSTAR and PreSTAR templates, here are some observations I have made when compiling a Traditional nIVD 510(k):

  • While this is a comprehensive template, you still need an understanding of 510(k) contents and the type of data that is required to fulfil the requirements.
  • I appreciate the administrative side of this template, and there is a reduction in hours in formatting and compiling.
  • As the sections are not numbered, develop a method for naming of attachment files as well as a system for page numbering as you do reference page numbers in certain sections.
  • Compile methodically to ensure sections are enabled or disabled correctly.
  • Use the automatic 510(k) summary as this will ensure the correct sections are included and may reduce unnecessary data from being included.

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