Review of FDA IDE (Investigational Device Exemptio
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Posted On: 05/23/2025 11:22:02 AM
Review of FDA IDE (Investigational Device Exemption) shows a technical and also a detailed submission review and analysis.
https://www.fda.gov/medical-devices/investiga...ption#risk
Is the FDA incompetent? "The FDA did not cite any deficiencies from its review of the proposed clinical study design. Rather, it cited certain findings from one of the two Bioresearch Monitoring (BIMO) audits of UHP’s initial 2019 clinical study that were conducted in 3Q/2024, and which the company had responded to on October 25, 2024 and again on April 14, 2025."
No adverse affects in the clinical trial and NO IDE DEFICIENCIES!!!!!
Get your shi_ together FDA many could be helped with the CelluSTAT gauze device!
$5-$10+
https://www.fda.gov/medical-devices/investiga...ption#risk
Is the FDA incompetent? "The FDA did not cite any deficiencies from its review of the proposed clinical study design. Rather, it cited certain findings from one of the two Bioresearch Monitoring (BIMO) audits of UHP’s initial 2019 clinical study that were conducted in 3Q/2024, and which the company had responded to on October 25, 2024 and again on April 14, 2025."
No adverse affects in the clinical trial and NO IDE DEFICIENCIES!!!!!
Get your shi_ together FDA many could be helped with the CelluSTAT gauze device!
$5-$10+
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