How to prepare an FDA eSTAR 510(k) submission
Ғылым және технология
In 2020, the FDA launched the new eSTAR pilot program. eSTAR is a PDF eSubmission that is an alternative to the eSubmitter software that the FDA has been developing over the years, and an alternative to the current FDA eCopy that is the primary method companies use to prepare a 510(k) premarket notification. The eSTAR template was created by reviewers and is actually easy to use (if you understand the basics of preparing a 510(k) in the first place).
The implementation plan for eSTAR was set back by the Covid-19 pandemic, but the FDA is accepting eSTAR submissions for 510(k) premarket notifications. This video provides an introduction to the templates and explains how Medical Device Academy is adapting its normal 510(k) workflow to use the templates. The templates are designed to ensure that the submitter includes everything that is required for a 510(k) submission and eliminates the need for RTA screening by the FDA. The process also eliminates the need to format 510(k) submissions for an FDA eCopy. We are able to use all of our existing templates for a 510(k) submission, the need for some of the templates is eliminated, and only our 510(k) cover letter template was modified specifically for use with eSTAR submissions.
Particular highlights associated with the eSTAR template include: 1) built-in workflows for creating a summary of the testing provided for sterilization validation and biocompatibility and sterilization, 2) a built-in checklist for software and firmware verification and validation documentation, 3) hyperlinks to the most recent FDA guidance documents for each section of the 510(k) submission, 4) the ability to attach non-PDF files up to 1GB in size; and 5) automatic verification that each section of the 510(k) is complete.
The FDA has not released formal guidance to accompany the eSTAR templates, but help features embedded into the template largely eliminate the need for instructions or guidance. One of the most interesting observations we had was related to the three big yellow caution statements which warn the user not to enter confidential information into the PDF form. It appears that there is the potential for FOIA requests to be fulfilled in a semi-automated way by exporting the XML content of an eSTAR submission. The attachments are not exported. Therefore, an FOI could consist of the content provided by the XML export rather than manually creating a redacted 510(k) submission of much larger file size (no more 2-year waits for an FOIA?).
If you have any personal experience with eSTAR submissions, questions, or related updates, please comment on our video below.
Пікірлер: 19
Thanks Rob, what a useful presentation.
@MedicalDeviceAcademy
3 жыл бұрын
Thank you, I am glad you found this presentation useful! Keep an eye out more will be coming out in the future.
This presentation covered eSTAR quite well. Many updates were made to eSTAR since this video was done. I made a couple notes while watching the video I would like to convey here. There are only 6 textboxes in eSTAR that have the yellow confidentiality statement, and the information in these will only be posted online after clearance if you choose to have eSTAR generate a 510(k) Summary for you. The other information in the textboxes will not be posted online after clearance, and can be marked as confidential. The XML produced from the Export button at the end is only intended for the user to be able to transfer contents from one eSTAR to another, it is not intended for FOI requests. eSTAR version 1.2 now prevents disallowed format types from being attached, and the popup that occurs (try attaching a .zip as an example), will provide the formats that aren’t allowed. We want to allow as many format types as possible, so we will managing problematic attachment types as we see them, rather than the other way around.
@MedicalDeviceAcademy
2 жыл бұрын
Patrick is one of the two people identified as "built by" at the bottom of the v1.2 eSTAR templates on the FDA website. Here's a link to download version 1.2 that was released on March 11, 2022: www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program Thank you very much Patrick for the additional information and corrections.
Great presentation! side note: PPI = protected patient information
@MedicalDeviceAcademy
9 ай бұрын
Thank you for the comment.
I'd heard of the eSTAR program before but did not expect it to be this way. It is crazy to think now a 510(k) submission could be a long FDA Form. I definitely think there is a lot of potential in this format. Can definitely see how it might speed up the submission process on the companies' end as well as on FDA's end. My only concern would be the ability to have different people working on different parts of the submission - I wonder if the ability to comment will be sufficient. I think I would have to do my first one to really see how the workflow is affected or hopefully improved. I think it would be nice if they updated the eSTAR so that by inputting your product code(s) it automatically expects you to have followed special controls/standards and then it just becomes a yes/no for each one and allows you to provide a justification for those not followed. Overall very excited to try this! Thanks for the video. Quick question - can we do Pre-Submissions using the eSTAR program as of right now? p.s. R.I.P. FDA Forms 3514, 3881...
@MedicalDeviceAcademy
3 жыл бұрын
Thank you for the comment Meri, and I'm glad you got a lot out of the video. The FDA Forms 3514 and 3881 would go away, and only one person can be editing the document at a time. Companies still need to determine which standards and special controls guidance documents that are applicable (just like a normal eCopy). I think using our table of contents template as a way of managing what needs to be done in each section will be the best approach in the short-term for how to manage an eSTAR submission, after our team has a few rounds of practice we might experience a jump in productivity and find a better way to manage eSTAR submissions.
nice sharing - keep it up.
@MedicalDeviceAcademy
3 жыл бұрын
Thank you very much. We will!
@khalliwalli-obaidfarooqui
3 жыл бұрын
@@MedicalDeviceAcademy welcome
Thank you. As a novice, I have a question. Are we still supposed to use eSubmitter for any purpose?
@MedicalDeviceAcademy
Жыл бұрын
I hate eSubmitter and never use it. The FDA has a webpage dedicated to eSubmitter, but I believe the ESG and CCP have completely eliminated the need for eSubmitter.
Where do I find information on personal lubricant standards?
@MedicalDeviceAcademy
Жыл бұрын
This question was answered during a webinar I recently recorded for our 510(k) course on the topic of voluntary standards. If you search the FDA database for recognized consensus standards, there are multiple fields that can be used to search for standards. The most helpful field to use for this type of search is the product code field. You can identify the product code for personal lubricants (i.e., NUC) from the classification database. When you enter "NUC" in the product code field of the recognized consensus standards database, you will get one result: ASTM D7661-10. This is the only recognized standard that I am aware of that is specific personal lubricants. All other recognized standards that could be applied to personal lubricants would be generally applicable, such as ISO 10993-5 and ISO 10993-10. Other generally applicable standards would be related to packaging, aging, and labeling.
Are vol 10 and 11 inverted in this?
@MedicalDeviceAcademy
2 жыл бұрын
Section 10 used to be Executive Summary and the FDA changed that to Device Description. Now Executive Summary is section 11. That happened a 2-3 years ago.
If someone makes a FOIA request after my eSTAR 510k is cleared, does the FDA send my competitor my 510k much faster? I've made foia requests before and the FDA takes forever. That is good for submitter, bad for the requester.
@MedicalDeviceAcademy
2 жыл бұрын
Great question. I asked a similar question to the FDA. They indicated the FOIA process is not going to change, and my theory that they XML export could be used to automate FOIA requests was not something that the FDA plans to do.