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Posted On: 02/03/2023 10:57:54 AM
Post# of 495
UEEC was wise to have engaged RCA in the PMA application process and it appears it may pay off. RCA has many former FDA employees so I believe there has been intervention on their part to speak to FDA? No facts JMO!
https://www.rcainc.com/medical-device/
UHP continues to advance its Premarket Approval application with the Food and Drug Administration. Last December, a batch lot of HemoStyp gauze
produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company’s human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premar et Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the company’s manufacturing process, which results will be included in its final PMA application.
$5-$10+
https://www.rcainc.com/medical-device/
UHP continues to advance its Premarket Approval application with the Food and Drug Administration. Last December, a batch lot of HemoStyp gauze
produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company’s human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premar et Approval. Samples of these additional lots are now undergoing similar laboratory testing procedures to confirm the consistency of the company’s manufacturing process, which results will be included in its final PMA application.
$5-$10+
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