Hi Rob, As we've been working on eSTAR, we've noticed that some critical sections, such as the Risk Assessment and Device Hazard sections, seem to be missing. Could you please guide us on how we might submit this additional information? Thank you for your assistance.
Certain sections of the FDA eSTAR are not used in 510(k) submissions. The eSTAR is intended for three types of submissions: 1) 510(k), 2) De Novo, and 3) PMA. The risk and hazard sections only appear for De Novo and PMA submissions.
Hi Rob, Thank you for the wonderful presentation. Quite Informative and helpful. Is FDA still excepting the Traditional 510k eCopy documents ? Thanks and looking forward to your response. Shabs
No the FDA is not accepting 510(k) submissions in the eCopy format anymore. That ended October 1 of 2023. The FDA eCopy is limited to SIR meeting requests, sprints, meeting minutes, and a few other types of submissions. You can submit an AI Response using the eCopy, but the preferred response is to resubmit the FDA eSTAR with "additional information" selected instead of "new submission" selected.
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.
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.
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...
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.
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.
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.
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.
Hi Rob,
As we've been working on eSTAR, we've noticed that some critical sections, such as the Risk Assessment and Device Hazard sections, seem to be missing. Could you please guide us on how we might submit this additional information?
Thank you for your assistance.
Certain sections of the FDA eSTAR are not used in 510(k) submissions. The eSTAR is intended for three types of submissions: 1) 510(k), 2) De Novo, and 3) PMA. The risk and hazard sections only appear for De Novo and PMA submissions.
@@MedicalDeviceAcademy Does it mean the 510k submission does not require risk and hazard sections?
Hi Rob,
Thank you for the wonderful presentation. Quite Informative and helpful.
Is FDA still excepting the Traditional 510k eCopy documents ?
Thanks and looking forward to your response.
Shabs
No the FDA is not accepting 510(k) submissions in the eCopy format anymore. That ended October 1 of 2023. The FDA eCopy is limited to SIR meeting requests, sprints, meeting minutes, and a few other types of submissions. You can submit an AI Response using the eCopy, but the preferred response is to resubmit the FDA eSTAR with "additional information" selected instead of "new submission" selected.
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.
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.
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...
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.
Great presentation!
side note: PPI = protected patient information
Thank you for the comment.
Thank you. As a novice, I have a question. Are we still supposed to use eSubmitter for any purpose?
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.
Are vol 10 and 11 inverted in this?
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.
Thanks Rob, what a useful presentation.
Thank you, I am glad you found this presentation useful! Keep an eye out more will be coming out in the future.
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.
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.
nice sharing - keep it up.
Thank you very much. We will!
@@MedicalDeviceAcademy welcome