Question (Guidance) Decision Comments/ Justification D1 Do any of the Yes Processing is considered – manufacturing step/s more than minimal manipulation alter the biological No Proceed to Question D2 – characteristics of the original cells or tissues? D2 Do any of the Yes Processing is considered – manufacturing step/s more than minimal manipulation alter the physiological No Proceed to Question D3 – functions of the original cells or tissues? D3 Do any of the Yes Processing is considered – manufacturing step/s more than minimal manipulation alter the structural No Processing is considered – properties of the original minimal manipulation cells or tissues? D4 Your understanding of the classification of your biological
Question (Guidance) Decision Comments/ Justification D1 Do any of the manufacturing step/s alter the biological characteristics of the original cells or tissues? Yes – Processing is considered more than minimal manipulation No – Proceed to Question D2 D2 Do any of the manufacturing step/s alter the physiological functions of the original cells or tissues? Yes – Processing is considered more than minimal manipulation No – Proceed to Question D3 D3 Do any of the manufacturing step/s alter the structural properties of the original cells or tissues? Yes – Processing is considered more than minimal manipulation No – Processing is considered minimal manipulation D4 Your understanding of the classification of your biological
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