The RAPS Convergence 2023, held in Montreal, went incredibly well. The event was perfectly organized, and industry experts had essential knowledge to share. One hot topic that got attention in multiple sessions was eSTAR, which is sensible given the system’s required use in medical device submissions.
Dr. Patrick Axtell, representing the FDA, gave a remote presentation that provided a deep dive into the details of “The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions.” Another essential talk came from Dr. Dhitri Roy of Essenvia, who guided attendees through the steps involved in transitioning to the now-mandatory 501(k) eSTAR submission process. Both of these sessions, as well as others on the topic, provided essential information to manufacturers, regulators, and marketers on this new process.
Deciphering the eSTAR Program with Dr. Axtell
Dr. Axtell’s opening line gave a clear definition of the eSTAR: "The eSTAR is a dynamic PDF template that guides applicants through the process of constructing their medical device submission.” This is certainly true, but doesn’t get at the real implications of the system. The eSTAR template is highly automated, taking the guesswork out of completing submissions before sending them to the FDA and helping manufacturers avoid long and costly RTA holds. The eSTAR template was made by the FDA and reflects their internal process for 510(k) submissions, as Dr. Axtell explained: "The content and logic of eSTAR complements our internal review templates for 510(k)s, de novos, and pre-submissions."
"The automation in eSTAR will automatically verify that eSTAR is complete, and therefore your review is not done with eSTARs, and your eSTAR cannot be put on an RTA hold."
Submitting With the CDRH Portal
Another key element in the eSTAR system is the CDRH portal. Dr. Axtell reviewed its key functions: This is the portal through which eSTAR templates are submitted, and it also detects incomplete eSTAR submissions, halt the submission process, and notify the user, which in turn “...prevents things like downstream hold letters and hassle.”
Navigating the eSTAR Website
People looking to explore the eSTAR program should start with a simple Google search for “FDA eSTAR.” This will quickly bring them to the FDA’s official eSTAR website. One thing Dr. Axtell made clear is that submission teams should take the time to read the entire website. It has extensive instructions and a constantly-growing FAQ page and "The vast majority of questions we get are addressed on that website."
The FDA’s eSTAR website features links to the three types of eSTAR templates:
Non in-vitro diagnostics.
Early submission requests (nicknamed "pre-Star").
Dr. Axtell emphasized the importance of downloading the correct eSTAR template: "If you don't download the right eSTAR, it'll eventually tell you that you did download the wrong one."
Common Technical Problems
Dr. Axtell mentioned one common bug affecting eSTAR templates that are opened with the Windows-only version of Adobe Acrobat Pro. This bug doesn’t affect 100% of templates, but it can lead to a delay when answering dropdowns or radio buttons in dynamic PDFs like eSTAR.
"Our center for Drugs is having an issue with it with their dynamic PDFs. But this bug does not affect any Mac versions of Adobe Acrobat Pro."
Because eSTAR functions as a standalone package that doesn’t communicate with external systems, the PDF reader is one of the only possible sources of bugs with the template. It’s also a good idea to review the extensive FAQ on the first page of the eSTAR template itself. This page contains the template’s version history including changes applied at different points, as well as answering common questions.
Completing the eSTAR
The first part of the eSTAR template that users can directly fill out is a page for specifying the nature of their submission. Dr. Axtell made it clear that accuracy here is essential: "Be sure you answer these questions accurately because different sections in the eSTAR will either show or hide based on your choices." In other words, incorrect information on the first page will make it impossible to find and fill out necessary sections for your device later in the process. Another key feature to be aware of is that eSTAR has color-coded indicators: Red sections must be completed, gray sections are optional, and green sections have been completed.
The blue question mark buttons throughout the template provide additional information about each section, which could include links to examples or images. It’s always a good idea to review this information before proceeding with a given section.
The eSTAR template also has the ability to detect inconsistencies between sections, such as using different device names or specifications in different parts of the template. "If it sees some inconsistencies, you'll get a pop-up message advising you," Dr. Axtell explained.
To conclude, Dr. Axtell emphasized the FDA’s long-term vision for eSTAR, focusing on a streamlined submission process that gets devices to market more quickly.
9 Key Takeaways from Dr. Patrick Axtell’s eSTAR Presentation
The Technical Screening Process: This process is optional, but it’s also the best way to make sure that all eSTAR responses are accurate and relevant. In addition to the technical review process, reviewers will manually inspect the submitted eSTAR template and all of its menus and attachments.
Checklists and Guidance: The technical screening process doesn’t have a clear checklist or specific guidance. The acceptance of an eSTAR submission comes down to the manufacturer’s correct use of the eSTAR template and the reviewer’s judgment about the accuracy and relevance of the information being submitted.
Accuracy is Important: Especially in the early sections of the template, accuracy is incredibly important, since incorrect information at this point will deactivate important sections later in the document, leading to incomplete submissions and costly delays.
Attachments Should be Relevant: Part of the FDA reviewer’s job is to check the relevancy and accuracy of any attachments, making sure that submissions contain at least one attachment document for each required attachment question. It should be noted that extraneous attachments, like blank documents or foreign-language versions of the same information will not hamper the technical review process as long as there is at least one relevant document included.
Responding to Additional Information Requests: If manufacturers are faced with requests for additional information, one thing they don’t have to do is duplicate their original efforts with the latest version of the eSTAR template. They can simply make edits and additions to their original submission, as long as they used the most up-to-date version at the time of their initial submission.
How to Provide Additional Information: Manufacturers have two options for providing additional information: They can edit and add attachments to their initial eSTAR submission, or send the requested attachments and information in an eCopy without using eSTAR.
Attachment File Types: While eSTAR will accept many file types, including PDFs, word documents, excel files, and videos, it will not allow the attachment of some files. Notably, submissions cannot include executable files, macro-enabled documents, or archive file types.
eSTAR Deployment Timeline: The FDA has a clear order in which they are planning to enable other types of content in eSTAR. They’re working to enable PMA content, 513g content, developing an internal IDE Smart review template, adding more Q subtypes, and completing the availability of IDE supplement types.
Health Canada Pilot Program: The FDA is currently working with Health Canada on a pilot program to test the feasibility of class three and four submissions, PMA contents, and using a single eSTAR submission for multiple regions. The FDA is collecting feedback and conducting surveys with participants to identify necessary changes and improvements to allow for this international rollout.
Dr. Dhriti Roy Guides us Across the eSTAR Gap
Dr. Dhriti Roy of Essenvia gave a packed and well-received presentation: “Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510K eSTAR Submission Process.” Her extensive experience in regulatory affairs made her the perfect person to highlight the importance of the FDA’s eSTAR submission process, which became mandatory on October 1.
The Transition to eSTAR Submissions
The obvious reason for Dr. Roy’s presentation, which she emphasized throughout, was the mandatory shift to eSTAR submissions starting on October 1. She started by explaining what exactly the eSTAR is: "eSTAR is an interactive PDF for 510K submissions. FDA created this template to enhance consistency and efficiency in the preparation and review of 510K submissions." Like Dr. Axtell, she mentioned that the eSTAR does not go through the RTA process, but it does go through virus scanning and technical screening.
The Historical Roots of eSTAR
The origins of eSTAR can be traced back to 1998, when the federal government started working to improve the electronic submission process for 510K submissions. "Several government acts and initiatives have been introduced to streamline and improve the electronic submission process for 510K," Dr. Roy explained, all of which have culminated in the October 1 eSTAR mandate.
eSTAR’s Advantages and Limitations
The eSTAR represents an undeniable step forward in streamlining the 510K submission process. It will be faster, easier to use, and less expensive, both for manufactures and for the FDA. Dr. Roy knows this firsthand. "To my personal experience, eSTAR provides a standard interactive PDF that makes sections better organized and more complete in comparison to eCopy Program." That being said, there are definitely some challenges with the existing process.
The real issue here is that, while eSTAR and eCopy have a lot in common in terms of how documents get to the FDA, eSTAR essentially demands that manufacturers follow its process. This is going to require new tools and serious reorganization for many firms. "It's a significant change. You need to understand the process changes. Do you foresee the new impact?" explained Dr. Roy.
"Success in adapting depends on preparation. Have you asked yourself if you require the necessary infrastructure?"
eSTAR Transition Best Practices
Dr. Roy’s extensive experience meant that she had plenty of practical advice on how to navigate the move to eSTAR. She demonstrated up-to-date knowledge of existing bugs like the Adobe Acrobat Pro issue as well as detailed tips for navigating each section and menu in the eSTAR PDF.
Dr. Roy also emphasized the importance of developing an in-house tracking system to work through the eSTAR process, rather than relying solely on the template: "I recommend creating or modifying a tracking system using Excel or your existing tool. It's best to discuss your plan with program management."
The Future of eSTAR
Near the end of her talk, Dr. Roy made it clear that eSTAR is here to stay, and that manufacturers will need to become adept at navigating the process eventually if they want to remain in business. Her final line was quite clear: “There is no other alternative.”
She also invited attendees to come see her at Essenvia’s booth for one-on-one discussion, and recommended Essenvia’s very thorough booklet on the essentials of the eSTAR process.
Mastering eSTAR with Essenvia
Essenvia has developed a next-generation platform for Medtech submissions like eSTAR, allowing manufacturers to streamline the submission process and get to market more quickly. Essenvia has an extensive library of expert-approved submission templates, intuitive autofill features that draw on integrated regulator databases, centralized workflow management that makes it easy for teams to divide the labor, and real-time regulatory intelligence to help you keep track of competitor products.
Dr. Roy emphasized the platform’s strong experience with eSTAR submissions: "We have completed more than 350 submissions processed through the Essenvia platform, including eSTAR."
To learn more about Essenvia book a quick demo.