Since its initial pilot and coming into force for non-exempt 510(k) submissions in October 2023, the FDA eSTAR Program continues to have a positive impact on the device industry, greatly facilitating the submission and regulatory review processes. This article provides an overview of the FDA eSTAR Program.
What is eSTAR by FDA?
One of the greatest challenges for all regulatory authorities is resource management and the FDA is no exception. With medical devices, including IVDs, encompassing a broad range of technologies in various degrees of novelty, in contrast to other types of regulated products, the volume and nature of the information to be processed for marketing clearance/authorization / clearance can vary significantly. With the COVID-19 pandemic, pre-existing resource challenges were exacerbated and came to ahead globally, including in the US.
The eSTAR is simply an interactive PDF form that provides a highly structured format guiding applicants through the process of preparing medical device regulatory submissions.
There are currently three PDF templates available from the FDA including:
1. Non-In Vitro Diagnostic eSTAR
For 510(k), De Novo, and Pre-Market Approval (PMA) submissions for non-in vitro diagnostic devices.
2. In Vitro Diagnostic eSTAR
For 510(k), De Novo, and PMA submissions for in vitro diagnostic devices.
3. Early Submission Requests eSTAR (PreSTAR)
For pre-submissions (a type of Q-Submission) for both non-in vitro and in vitro diagnostic devices although at the time of this publication, this is still in Beta.
Benefits of eSTAR
Several benefits of eSTAR were touted by the FDA in the lead-up to its mandatory use and with the integration of feedback from the pilot and early use of the form (currently in Version 5), these benefits have been demonstrated effectively, including:
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- Elimination of the Refuse to Accept (RTA) review for 510(k)s. Given the highly structured manner of the file, including built-in forms required for 510(k) submissions (e.g. Truth & Accuracy Statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881) and indication of the files level of completeness, the RTA review has become redundant and saves time for the submitter whilst freeing up resources at the FDA.
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- Complements the FDA reviewer’s internal Submission Memo and Review Template (SMART) used to review the submission and restricts the provision of certain information in a highly structured/controlled structure, thereby greatly facilitating the review process (i.e. the reviewer can easily locate information within the form).
- Has integrated auto-fill functions to avoid errors when the same information is necessary in multiple locations across the submission and includes integrated databases to ensure that information for device-specific guidance, classification identification, and standards information is completed correctly (and consistently).
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eSTAR Compilation
Organizations requiring or choosing to submit the relevant eSTAR begin the process by simply downloading the appropriate eSTAR PDF from the FDA’s website, and saving the file before opening it. Once saved and opened, submitters will gradually work their way through the form by following the instructions and information provided in the form – only those elements relevant to the submission will be expanded for further completion by the submitter.
Size Limitations and Multimedia Guidelines for eSTAR Submissions
In the case of submissions to CDRH, submitters must ensure the size of the eSTAR does not exceed the 4 GB limit as the portal is incapable of processing applications of this size. Furthermore, attachments to the eSTAR should not exceed 1 GB. If it is not possible to adhere to these limits, CDRH does provide instructions on how to proceed on the portal. In these cases, the submission size limit is 100 GB.
The eSTAR greatly facilitates the inclusion of multimedia in the submission, however, images and videos must be compressed in a Microsoft Windows-compatible format (e.g. JPEG, AVC MP4, HEVC MP4) with the FDA highly recommending the use of HVEC video compression, where necessary.
To facilitate the review of similar content, the FDA also requests that similar content be combined into a single attachment (e.g. a single Software Requirements Specifications attachment) with the use of integrated bookmarks or table of contents.
eSTAR Submission
eSTARs are submitted either through the online CDRH Portal or CBER Portal depending on the center responsible for processing the submission.
While eSTAR has eliminated the need for a RTA review, the FDA does perform technical screening of submitted eSTARs to identify any viruses or other technical issues that could impact the review process. Where an eSTAR does not pass technical screening, the submission is placed on an early Technical Screening hold for 180 days until a complete replacement eSTAR is submitted.
Following successful screening, the submission goes through the standard FDA review process.
Learn More About the FDA eSTAR Program with MedEnvoy
This article provides an overview of the FDA eSTAR Program. If you have any questions regarding US medical device regulatory requirements, need to file a 510(k) or other regulatory submission to the FDA, or require a US Agent, get in touch.