Over the years, the FDA has had several 510(k) submission programs to make the process more streamlined and effective.
This was achieved by going from paper systems to e-copies, e–submitter and Electronic Submission Gateways (ESG).
In 2021, eSubmitter was discontinued after the eSTAR Pilot Program was launched in 2020.
So far, eSTAR has been voluntary but from October 1, 2023, eSTAR will be mandatory for all 510(k) submissions.
The electronic Submission Template And Resource (eSTAR) program launched by the FDA is intended to enhance the quality of submissions for medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review. The eStar program is currently voluntary, but starting October 1, 2023, all 510(k) submissions, unless otherwise exempted must be submitted as electronic submissions using eSTAR.
The eSTAR is an interactive PDF form that guides you through the process of preparing a 510(k) or De Novo request. Also note that since the e-STAR uses automatic verification, the FDA does not intend to conduct a Refuse to Accept (RTA) review for eSTAR submissions.
FDA has also provided an updated guidance for Electronic Submission Template for Medical Device 510(k) Submissions that outlines the process for additional help.
So, what do you need to know about this interactive pdf?
Well, first you need Adobe professional to be able to fill in data. It won’t open in your web-browser, so you must download the pdf to your computer to be able to use the program. When you open it for the first time it might be surprising that it is only 3 pages long. But have no fear, as you move along and tick checkboxes, new pages will open. It’s like an adventure in Dungeons and Dragons. And for each section you have the possibility to add attachments. If possible, add only 1 (document) attachment in each section to make the review easier to handle. But you can attach various types of files, including video.
As you fill in each row in the respective section, the banner on the left in the template goes from red to green. When the entire section is completed, the top banner goes green as well. You are now ready to go to the next level.
A practical approach with regards to collection of the supporting documents – do not attach draft version of your pdf since you will not be able to edit them once attached. A recommendation is to keep them in a separate folder until they are approved and valid. If you need to change a file already attached, you must delete the file and attach the new one.
Compared to the previous 510(k) submissions template, eSTAR is a giant leap forward and seems to be very user friendly. If weshould say something less positive about the program, is that it sometime takes a while for the pdf to process the information and open the next section. But not to the extent that it poses an actual problem.
Generally, regulatory updates cause additional work and make life in general more challenging for manufacturers, but in this case, it nearly makes a 510(k) submission fun. Or is it just us?
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