Do your d/d! UEEC IMO should be ready for the subm
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Posted On: 01/15/2024 10:56:16 AM
Do your d/d! UEEC IMO should be ready for the submission by now hopefully?
Just to reiterate for newbies...10/5 pr stated "In anticipation of re-submitting updated PMA information, UHP has engaged regularly with the FDA. Through this engagement the Company was recently notified that it had been selected as the first medical device application for Premarket Approval (PMA) to be submitted and evaluated using the FDA’s electronic Submission Template and Resource (“e-STAR”) platform. The eSTAR is an interactive, automated PDF form that guides applicants through the process of preparing a comprehensive medical device submission."
So what does AI say....
I assume you are asking about the release date of eSTAR for PMA submissions. According to the FDA, eSTAR is now available for voluntary use for certain PMA submissions
JMO sounds life FDA & UEEC have been working in tandem?
$5-$10+
Just to reiterate for newbies...10/5 pr stated "In anticipation of re-submitting updated PMA information, UHP has engaged regularly with the FDA. Through this engagement the Company was recently notified that it had been selected as the first medical device application for Premarket Approval (PMA) to be submitted and evaluated using the FDA’s electronic Submission Template and Resource (“e-STAR”) platform. The eSTAR is an interactive, automated PDF form that guides applicants through the process of preparing a comprehensive medical device submission."
So what does AI say....
I assume you are asking about the release date of eSTAR for PMA submissions. According to the FDA, eSTAR is now available for voluntary use for certain PMA submissions
JMO sounds life FDA & UEEC have been working in tandem?
$5-$10+
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