Saleh:
Agree with your argument based on example below you bring up -i.e. raises doubts more than definitive answers for you .
Hence-as suggested earlier - wise for you to push on a help support ticket towards the eSTAR group-they will in turn end up bubbling your issue to the actual FDA 510k CDRH reviewers who will review and analyze point by point eSTAR vs actual US FDA reviewer template requirements BEFORe you submit !
My understanding is that eSTAR and CDRH 510 reviewers template are identical (* i.e. allows bypass of RTA review
if eSTAR completed correctly) but there remains the whole issue of substantive review that even FDA eSTAR might have overlooked. Hard to say.
Best for you to consult with eSTAR now then take it from there.
------------------------------------------
FYI
We've dealt with the eSTAR developer team early on last year- know how they work.
We even pointed out some Adobe PDF anomalies (editing online without downloads!) and still waiting on our
21 CFR Part 11 questions issue promised Jan 2022 month end that eSTAR's team consulted with internally were supposed to get back to eSTAR team with.
More on secure cloud-hosted eSTAR below, fyi:
-
§ eSTAR after uploaded online can function and work well on a Teams based cloud environment, i.e. apply native out-of-the-box Sharepoint 21 CFR Part 11 compliance (version control.audit logs etc)- no downloads of eSTAR needed to work with and subsequent version '
leaks' (* eSTAR export/import of XML based data is replacement style not additive*)
-
§ cloud hosted preprinted-flat pages of 21 eSTAR for commenting and collaborating (* native eSTAR does not allow on the actual 'locked' template PDF)
-
§ adding
eSTAR specific Sharepoint tasks (completed with subtasks /resources assignments, Gannt Charts, predessesors) pegged or anchored againts each eSTAR FLAT page with eSTAR flat pages IMAGES complete with collaboration comments for real-time sharing inside Teams, etc.
These and more are what eSTARHelper is all about-see our site eSTARHelper.com if there is interest to know better what's possible, i.e. how to 'embrace and extend' eSTAR on secure, encrypted and fully authenticated Microsoft cloud within Teams'.
Have a good weekend and good luck with eSTAR.
Ram Balani
------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC
www.estarhelper.comAmawalk , New York
rbalani@fdasmart.com2019130558
https://tinyurl.com/2wkxp69yon US FDA eSTAR for 510(K)
------------------------------
Original Message:
Sent: 18-Feb-2022 18:20
From: Saleh Riazi
Subject: Use of eSTAR 510 (K) submission for a labeling change
Thanks Ram, that is correct, our decision to submit as a traditional 510(K) was based on this guidance document. Please see Example B.9 below.
But we are not sure how to address the sections that don't apply to this labeling change submission in eSTAR.
-------------------------------------------------------
Example B.9
Change: The submitter wants to change the labeling of their blade-form endosseous dental
implant from "Safety in MRI Not Evaluated" to "MR Conditional."
Relevant Questions:
A - Is it a change to the manufacturer's own device?
Yes, the submitter is the manufacturer of the predicate device.
B - Are performance data needed to evaluate the change?
Yes. Non-clinical performance testing to support SE should be provided by manufacturers
seeking MR Conditional labeling for a device that contains metallic components. The FDA
guidance document Establishing Safety and Compatibility of Passive Implants in the
Magnetic Resonance (MR) Environment57 provides recommendations for such testing.
C - Is there a well-established method to evaluate the change?
Yes. There are FDA-recognized voluntary consensus standards such as ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F211962 for MR compatibility testing of passive implants.
D - Can the data be reviewed in a summary or risk analysis format?
No. Although there are consensus standards for all test methods, FDA does not believe this data can be summarized because the SE determination will depend on FDA's interpretation of the underlying data to support the MR Conditional label. This includes interpretation of device-specific pass/fail criteria and results that are not addressed in the standard. This is referenced in section III.E as an anticipated common scenario for when data may be unable to be summarized.
Decision: Change cannot be reviewed in a Special 510(k).
----------------------------------------------------------------------------------------------------------------
------------------------------
Saleh Riazi
Regulatory Consultant
San Jose CA
United States
Original Message:
Sent: 18-Feb-2022 14:00
From: Ram Balani
Subject: Use of eSTAR 510 (K) submission for a labeling change
Not sure regarding Special vs Traditional approach to your own legally marketed 510K device already on the market but see this below and attachment:
--------------------------------------------------------------------------------
"I. Introduction
This guidance provides the Food and Drug Administration's (FDA) current thinking on
premarket notifications (510(k)s) appropriate for review as a Special 510(k).
The intent of thisguidance is to describe an optional pathway for certain well-defined device modifications where
a manufacturer modifies its own legally marketed device, and design control procedures produce
reliable results that can form, in addition to other 510(k) content requirements, the basis for
substantial equivalence (SE). This guidance clarifies the types of technological changes
appropriate for review as Special 510(k)s.
Specifically, within the scope of appropriate changes,
we are including certain design and labeling changes, including changes to the indications for
use, by focusing on whether the method(s) to evaluate the change(s) are well-established, and
whether the results can be sufficiently reviewed in a summary or risk analysis format."
---------- And this below -also from the same Guidance link below ------------------
"Subject to the framework identified in sections III.A-E of this guidance, a design or labeling
change to an existing device (including certain changes to the indications for use) may be
appropriate for a Special 510(k) when:
· The proposed change is submitted by the manufacturer legally authorized to market the
existing device;
· Performance data are unnecessary, or if performance data are necessary, well-established
methods are available to evaluate the change; and
· All performance data necessary to support SE can be reviewed in a summary or risk
analysis format."
--------------------------------------------------------------------------
Check out FDA's Guidance here -
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program
Best you review the guidance well then reach out to FDA's eSTAR-then they do internal CDRH outreach back to you?
Ram Balani
------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
Original Message:
Sent: 18-Feb-2022 13:09
From: Saleh Riazi
Subject: Use of eSTAR 510 (K) submission for a labeling change
Thank you so much Ram,
This is very helpful and we will make sure to reach out to eSTAR support as well.
But one point about the type of submission. Based on our experience with MR claim submission, we are submitting this as a Traditional and not a Special. Doing so, the "Applicable Section Introduction" in your post above doesn't show up. Therefore those additional, "Reprocessing", "Sterility" and etc. Still shows up in the form.
Thank you
------------------------------
Saleh Riazi
Regulatory Consultant
San Jose CA
United States
Original Message:
Sent: 18-Feb-2022 12:34
From: Ram Balani
Subject: Use of eSTAR 510 (K) submission for a labeling change
Saleh,
Are you doing a Special 510K with eSTAR?
See attachment, seems it would not be necessay if the only change is in the labeling for the new MRI claim and all else remain the same-that is up to you to determine and indicate on the eSTAR nIVD PDF template.
I guess what I am saying to be clear-you need to 'tell' eSTAR first the specific scenario with the check boxes ticked on or ticked off-see attachment. eSTAR directions tells you to do so-see attachment.
BTW
I would run a quick query to the FDA on this to be sure however-i.e. send to eSTAR Support email first-they will likely check with their regulatory associates based on our past experience inquiring about 21 CFR Part 11 compliance on the actual PDF (nIVD) container .PDF file to which all sorts of attachments are added.
Ram Balani
eSTARHelper LLC
eSTARHelper.com
------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
Original Message:
Sent: 18-Feb-2022 11:46
From: Saleh Riazi
Subject: Use of eSTAR 510 (K) submission for a labeling change
Hello RAPS community,
We are in the process of preparing a 510(K) submission tp add MRI claim to the our Class II products. We also are using eSTAR to prepare the submission. As it goes, we are using our on-market product as the predicate and "only" adding an MRI claim to the labeling of the products.
My question is:
Using eSTAR, do we still need to complete the sections for "Reprocessing, sterility and shelf-life" and "Biocompatibility" of the form?
Thank you so much
------------------------------
Saleh Riazi
Regulatory Consultant
San Jose CA
United States
------------------------------