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I know and I don’t know if saying that this could have been handled a lot better is completely accurate… but I think we all think things could have and should have been done a lot better.. cleaner and more efficiently… nonetheless… it actually does take around 6-7 Years to get the approval that we are looking for… maybe not for Johnson & Johnson because the wallet is a bit bigger and a dedicated department to getting this done comes in pretty handy.. Time will tell all
Actually Wave I’ll do whatever I want and I obviously don’t need your permission to do so.. My post is to avoid things like this.. I’ll give you credit yes I unleashed but what I unleashed was overdue to a putrid individual that just wants to bash a company with old PR’s and avoids any response on a valid legitimate question.. as far as what I wrote I am sorry if I offended your virgin ears but I thought we were all big boys and big girls on this page.. not justifying the actions just speaking truth as to what I think of the individual or even individuals that are in the same class as that person… maybe you will understand that this is a classic case of keyboard tough guy and a bully that wants to sound credible but has zero credibility because he will not reply to any questions that are sent his way.. go back on my messages I’ve asked him legit questions and simply does not reply.. so yes my opinions on him stick, they stay in place and as far as I’m concerned are valid.. Putting my prior war crimes aside I think my last post was a solid piece of advice
$UEEC scam has been in PMA evaluation since 2017 according to the filings. And they still neglect to do the paperwork properly. It is merely a stock selling scam.
Keep in mind the prior reviewers who I understand opted to retire upon the Trump administration offer may be working the UEEC case once again. What are you worried about shoon boy? You don't have any skin in the game!
$5-$10+
1. Failure to submit an IDE application to FDA and failure to obtain FDA approval prior to beginning an investigation for which FDA’s approval is required [21 CFR 812.20(a)(1) and (2).
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
2. Failure to ensure proper monitoring of the investigation [21 CFR 812.40].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
3. Failure to secure clinical investigator’s compliance with the signed agreement, the investigational plan, applicable FDA regulations, and any other conditions of approval imposed by the reviewing IRB or FDA, or if compliance could not be obtained, failure to discontinue shipments of the device to the investigator and terminate the investigator’s participation in the investigation [21 CFR 812.46(a)].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
4. Failure to immediately conduct an evaluation of any unanticipated adverse device effects and failure to report results of such an evaluation to FDA and to all reviewing IRB’s and participating investigators within 10 working days [21 CFR 812.46(b)(1) and 21 CFR 812.150(b)(1)].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
5. Failure to maintain accurate, complete, and current device shipment and disposition records [21 CFR 812.140(b)(2)].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
So agreed and in this regard we can speculate that those previous reviewer(s) originally charged with the UEEC PMA/IDE review have been called back to arms after their release from employment or election to retire from service and are now proceeding forward. You bet the reason for "As of the current date, the FDA states that its review of the company's response is ongoing."
$5-$10+
Volume created through wash trades fools nobody.
"Where as the FDA is fucking useless, they do no work. There is no reason for any of those people to even get paid."
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