If you are keeping abreast of FDA’s medical device efforts, then you know that as of October 1, 2023, all original 510(k)s are required to be submitted using one of FDA’s electronic Submission Template and Resource (eSTAR) forms. FDA’s webpage provides plenty of background information. The biggest potential upside to submitters is that eSTAR’s standardized format is intended to ensure that submissions are complete, i.e., have the minimum information FDA needs to begin its review of the submission. A big upside for FDA reviewers is that eSTAR organizes the information in a way that matches FDA’s internal review templates. But there’s an important downside to eSTAR: It makes it more difficult to “tell your story” if your story doesn’t fit neatly into the template. eSTAR forces you to tell your story their way instead of your story your way.
Let’s illustrate the point with cytotoxicity testing, which is routinely required by FDA for devices that directly or indirectly contact a patient. If the one of the most common methods was used (MEM elution), eSTAR requires 15 different questions to be answered, including questions like “Was the extract diluted, filtered, or was the pH adjusted?” and “Extract/Test Article is clear?”. None of the 15 questions are unusual; all of them are part of a typical MEM elution cytotoxicity report and the report can be attached to the eSTAR form. (Best practice is to always include the report!)
But what happens, for instance, if the extract has particulates? eSTAR offers a text box for comments and a detailed explanation can be given in an attachment. But a potentially bad impression has already been made. Your entire biocompatibility strategy was in accordance with best practices, you conducted the testing in accordance with Good Laboratory Practice, you thoroughly investigated the unusual result, and your risk assessment concluded that the device has an acceptable biocompatibility profile. All of that information is buried in an attachment that comes at the end of the section. The first thing a reviewer sees is not your hard work and excellent science – they see an unusual result.
We certainly do not advise omitting or burying adverse results. On the contrary, over MED’s 40 year history, we have helped researchers, developers, manufacturers, and most importantly, regulators, understand unexpected results by thoroughly investigating them and providing context. And we’re not nostalgic for the past: eSTAR will greatly simplify many administrative aspects of the submission process.
And yet… The biocompatibility section is perhaps the most striking example of the increased difficulty in telling your story your way, but similar difficulties occur in many other places. The “proposed shelf-life” box allows for only one time period. Many sections of eSTAR end with attachments, rather than starting with an attachment or text box summary. The optional Executive Summary is at the end of the form, not the beginning.
The advent of eSTAR has made it slightly more difficult to tell your story your way, but not impossible. Telling your story to a regulator takes considerable skill – not just good writing skills, but excellent scientific skills, a deep understanding of regulatory agencies, and the skillful ability to persuade a reviewer to agree with your science-based conclusions.
MED has successfully helped researchers, developers, and manufacturers to tell their stories to FDA for 40 years. Do you need help in telling your story? Let us know. Whether for an eSTAR 510(k) or another type of submission, we’re happy to help. Contact us today 855.463.1633 | email@example.com | medinstitute.com.
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