fda_report_outln

fda_report_outln - Efficacy testing in animals (animal...

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FDA REPORT Outline Description of the Device Indication Intended Use FDA Classification Preclinical Tests Laboratory functional tests Performance tests Mechanical tests (if relevant) Biological (Safety) Tests (FDA Tripartite Guidance)
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Unformatted text preview: Efficacy testing in animals (animal models related to the human use of the device) Clinical Tests Patient population Controls Sample size (statistical power calculation) Outcome variables to be measured Informed Consent Form...
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