In September of 2018, the FDA took their first step to improve and modernize the process of a 510(k) electronic submission. This commitment was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was enacted on July 9, 2012, amending the FD&C Act by adding section 745A.
As part of this Act, a program called Electronic Submission Template and Resource or eSTAR was started as a pilot program to create a collection of questions, text and prompt within a PDF template to guide and standardize users through a highly formatted submission that can easily and efficiently be reviewed by the FDA.
Currently, eSTAR is a voluntary process that will become mandatory starting October 1, 2023. It is free to use by medical device applicants wishing to submit a 510(k) or a De Novo to the CDRH but is not to be used for combination products. Although it’s currently free to use, the standard submission fees for 510(k) and De Novo’s still apply.
A Refuse to Accept (RTA) review (a preliminary review used to ensure the submission is complete) will not be conducted on submitted eSTAR templates as the eSTAR template replaces this checklist and will state if the template is complete or incomplete on the first page. If the eSTAR does not have a completed status, it will not be reviewed by the FDA.
The two templates provided by the FDA are PDF forms that can be filled out and saved, with attachments. The image below shows the device description page of the non-IVDR form. The other form is used for IVDR submissions. When using the form, red bars will appear in front of any required questions that have not yet been answered. Bars will turn green when all associated questions in a section have been completed. Gray bars indicate an optional question. As questions are answered, additional dropdown’s may appear that can require users to add additional information. Additionally, pop-ups with FDA guidance will appear for certain sections as needed throughout the file.
It is important to note that while the RTA process is not necessary the FDA review timelines remains the same, although the hope is that the streamlining of the submission should make the review easier and more efficient for the FDA reviewer.
Another process improvement from the FDA perspective is the Customer Collaboration Portal which was set up and opened on October 2022 to all users who can register and then can submit a CDRH eCopy or eSTAR premarket submission online. Additionally, users of the portal will be able to track the submission progress through the portal, providing some valuable transparency and provide updates the submitters without reaching out to the FDA reviewers.
The second option to submit a premarket submission to CRDH requires a printed cover letter with an accompanying eCopy (CD, DVD or USB drive) containing the eSTAR PDF. Note that if the PDF submission exceeds 1 GB in size, it could delay the process, so high-resolution videos and images should only be included when necessary.
Some important notes to keep in mind with the introduction of the eSTAR is that it does not need to comply with the FDA’s eCopy Guidance document, however, any additional files that are provided with the eSTAR PDF submission will need to comply with it. The FDA strongly recommends not providing additional files with the eSTAR PDF, though, as you already will be embedding your documents within the eSTAR template itself.
An eSTAR submission will contain a larger number of files (as they will be embedded in the PDF eSTAR template) than traditional submissions, which are usually combined into one PDF file. We recommend preparing your entire submission before filling out the eSTAR template to minimize the need for reworking the submission.
Additionally, FDA and Health Canada announced on January 10th 2023 that they would be launching a joint pilot program, accepting one single eSTAR to both agencies. This is an exciting pilot as it could lead to much greater synchronization across the US and Canada for future regulatory submissions across both countries at the same time, reducing administrative burden and speeding up timelines.
If you have any questions about the contents of this post or need assistance with a medical device premarket submission, Accurate Consultants is here to help guide you through the entire process from start to finish. If you are interested, please send us an email at info@accuratefdaconsulting.com for a timely response and quote for the required services.
Sources
Voluntary eSTAR program. Updated 11/14/2022. Food and Drug Administration. https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program
Health Canada and FDA eSTAR pilot. Updated 1/10/2022. Food and Drug Administration. https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot