The road ahead......Even with FDA approval the jou
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Posted On: 03/28/2024 5:55:49 AM
The road ahead......Even with FDA approval the journey for UEEC hemostyp products is just beginning. FDA will monitor with reporting requirements for with post approval annual data. Lets hope for the best and that would be a straight buyout per share!
FDA Approval of Class III Medical Devices
After receiving FDA approval for a Class III device, manufacturers are still subject to different requirements. In the approval letter, FDA may specify specific post-market requirements such as registry efforts, annual data submissions, or post-market clinical trials. Manufacturers will have to periodically submit reports to FDA about their class III devices. These reports are typically yearly reports called “annual reports” and include information like annual sales data, trending complaints, metrics on patients or usage, and a literature search. However, FDA may request annual reports quarterly or biannually.
$5-$10++
FDA Approval of Class III Medical Devices
After receiving FDA approval for a Class III device, manufacturers are still subject to different requirements. In the approval letter, FDA may specify specific post-market requirements such as registry efforts, annual data submissions, or post-market clinical trials. Manufacturers will have to periodically submit reports to FDA about their class III devices. These reports are typically yearly reports called “annual reports” and include information like annual sales data, trending complaints, metrics on patients or usage, and a literature search. However, FDA may request annual reports quarterly or biannually.
$5-$10++
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