S
sokku
Hello
Can anyone share or update the step by step process flow chart of US FDA PMA approval process?..
Can anyone share or update the step by step process flow chart of US FDA PMA approval process?..
FDA says the below in (broken link removed)
Industry requested a detailed flowchart that would identify the type of supplement to be submitted based on any specific change for any device. FDA understands that there is a general desire among PMA applicants for such a detailed flowchart or easy-to-use paradigm. However, FDA believes the complexity and variability of class III devices makes it unfeasible to develop such a flowchart.
Industry requested a detailed flowchart that would identify the type of supplement to be submitted based on any specific change for any device. FDA understands that there is a general desire among PMA applicants for such a detailed flowchart or easy-to-use paradigm. However, FDA believes the complexity and variability of class III devices makes it unfeasible to develop such a flowchart.
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