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Posted On: 12/19/2024 8:24:36 AM
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https://www.greenlight.guru/blog/fda-medical-...al-process
Everything you wanted to know about FDA approval?
"On November 29th, the company submitted to the FDA an Investigational Device Exemption application (IDE), the approval of which is a precondition to enroll patients in the planned study. The IDE contains, among other elements, a proposed study protocol for the testing of approximately 30 subjects across 3-5 surgical facilities, with the objectives of confirming non-inferiority and superiority, as well as safety, of CelluSTAT versus the standard of care in open surgical procedures in the abdominal space. The FDA generally seeks to respond to IDE applications within 30 days , subject to availability of resources."
Nothing is guaranteed when dealing with the FDA! Do your due diligence analysis!
$5-$10+
Everything you wanted to know about FDA approval?
"On November 29th, the company submitted to the FDA an Investigational Device Exemption application (IDE), the approval of which is a precondition to enroll patients in the planned study. The IDE contains, among other elements, a proposed study protocol for the testing of approximately 30 subjects across 3-5 surgical facilities, with the objectives of confirming non-inferiority and superiority, as well as safety, of CelluSTAT versus the standard of care in open surgical procedures in the abdominal space. The FDA generally seeks to respond to IDE applications within 30 days , subject to availability of resources."
Nothing is guaranteed when dealing with the FDA! Do your due diligence analysis!
$5-$10+
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