What sticks out in the recent PMA update.... JMO
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Posted On: 10/09/2023 9:02:27 AM
What sticks out in the recent PMA update....
JMO but the comment "For example, the automatic verification process within eSTAR negates the need for a "Refuse to Accept" review, among other time-consuming administrative processes. The eSTAR has been used extensively in medical device applications for 510(k) approval and UHP is honored to have been selected as the first to submit its Premarket Approval application through this FDA resource."
Our FDA invitation to submit our PMA through eStar is a big plus IMO.
$5-$10+
JMO but the comment "For example, the automatic verification process within eSTAR negates the need for a "Refuse to Accept" review, among other time-consuming administrative processes. The eSTAR has been used extensively in medical device applications for 510(k) approval and UHP is honored to have been selected as the first to submit its Premarket Approval application through this FDA resource."
Our FDA invitation to submit our PMA through eStar is a big plus IMO.
$5-$10+
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