Many thanks Pallavi for reaching back.
Yes-we know of the Virtual Town Hall Meeting hosted by CDRH Office of Product Evaluation and Quality.
We are late-comers attendants but we are committed to attend each and very one now going forward since the last one October 6th. I did not realize how super informative these were until an IVD client approached us for assistance recently.
Back to my original post-I suspected the Decline to Review was because of recent, modified priorities of CDRH reviewers and indeed that was confirmed when their letter from FDA was finally shared with us soon after. I have extracted FDA CDRH' modified review priority below for the group's convenience.
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A: We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized. We prioritize review of EUA requests for tests taking into account a variety of factors, as discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product. We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput, widely distributed tests). For at-home and home collection tests, we have prioritized review of EUA requests for diagnostic tests (molecular and antigen) in light of our current assessment of the public health needs.
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Apart from above, just sharing FYI-we discovered part of the issue for their misfired EUA attempts is that the US FDA search sites are behind the 8-ball so to speak and with way too much ( a firehose of) rules and regulations, guidance, template directives, etc. one can easily get lost!
The client/ manufacturer's past submitted pre-EUA (they presumed the same as an actual EUA) was haphazardly done and partially because US FDA provides such poor searching on their website for (1) CFRs (34 CFRs on medical devices), (2) US FDA medical device general guidances (105 total) including those (3) specifically on Covid-19 (another additional 76 in total), and with (4) Virtual Town Halls transcripts (71 total) for Lab and Commercial Covid-19 Test Manufacturers.
Imagine. for example, searching ALL 71 Town Hall recording transcripts since March 25-2020 where one is trying to seek the answer to the question of which of the hosted 71 PDF transcripts references:
'saliva' AND 'home' AND 'antigen'
and that search is done FROM ….here below …..at the US FDA website (bottom of page) hosting all Virtual Town Hall meeting recorded transcripts started on the onset of Covid-19 March 2020 –
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-coronavirus-covid-19-test-development-and-validation-10202021-10202021 Yikes !!
Happy to say -FDASmart has remedied this issue for our clients with the Town Hall transcript searches for ALL recordings.
We have now hosted in eSTARHelper and SmartSearch enabled All 71 PDF transcripts making the same search click away.
See attachment sample of the same search. We plan to host the ALL Town Hall transcripts on our eSTARHelper Auxiliary Portal site soon for FREE use by the public at large.
Will post on the RAP group when we are ready, i.e. complimentary searching as in FREE and merely requires email address registration for MIcrosoft site authentication, i.e. (4) listed above will be on our open Free portal site with mere registration, the others ((1) (2) and (3) on per user subscriber basis.
For more on eSTAR from FDA CDRH see this (my article explains eSTAR in a nutshell for introductions as to why, where, how the US FDA crafted this sophisticated PDF FREE to download at the FDA website soon to become MANDATORY FOR ALL 510Ks Premarket Notification per CDRH announcement to come.
https://tinyurl.com/f6dbbpcx eSTAR 510K PDF template will be MANDATORY FOR ALL 510Ks!
Enjoy.
Thanks again for reaching back Pallavi. Much appreciated.
Ram Balani
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Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC
Amawalk , New York
rbalani@fdasmart.com2019130558
https://tinyurl.com/2wkxp69yon US FDA eSTAR for 510(K)
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Original Message:
Sent: 18-Oct-2021 10:22
From: Pallavi Sharma
Subject: Covid-19 EUA (Emergency Use Authorization) -FDA Decline to Review
Hi Ram,
It may help you!
Virtual Town Hall for SARS-CoV-2 Test Developers
On Wednesday, October 20, 2021, from 12:15 pm - 1:15 pm ET, the U.S. Food and Drug Administration (FDA) will host the next virtual Town Hall for SARS-CoV-2 test developers. During this Town Hall, the FDA will answer technical questions about the development and validation of tests for SARS-CoV-2. |
There will be an opportunity to ask questions live on the call, but questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov.
- Submit questions by Monday, October 18, 2021 by 12pm ET
- In the subject line of the email, state "Question for the COVID-19 Test Virtual Town Hall"
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Pallavi Sharma
Florham Park NJ
United States
Original Message:
Sent: 16-Oct-2021 02:35
From: Ram Balani
Subject: Covid-19 EUA (Emergency Use Authorization) -FDA Decline to Review
Dear ALL:
We are assisting an immunoassay kit manufacturer firm (LFIA-Lateral Flow Immuno Assay) for nucleocapsid protein antigen of SARS-CoV-2 virus. The kit is exciting and new, i.e. at-home saliva speciment-none of that pesky nasopharyngeal swabs and qualitative yes/no Covid infected results read visually on a test at-home cassette, simple to use with clear-cut instructions just like a pregnancy test.
US FDA issued the firm a Decline to Review their EUA-not clear why --i.e. this is novel, a great addition to testing at the PON (Point of Need) without Health Provider hassles, e.g. can be done on the fly at airports, sport stadiums, schools, restaurants, etc
Has ANYONE had a experience with an EUA for Covid IVD testing that was Declined for Review ?
US FDA has ton of Virtual Town Hall transcripts (70 of them ,each one 25 pages or more but as typical of FDA-no search or database once do to find the transcripts that for example would address "Decline" "review" "Antigen" 'saliva" Who has time to scour and read 70 x 25 pages of text these days?
Can anyone assist with this ?
Any help or leads or information or even explanation would be much appreciated.
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Ram Balani
CEO
FDASmart Inc.
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
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