US FDA PMA (Pre-Market Approval) Process Flow Chart Example

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Ajit Basrur

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FDA says the below in http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089274.htm

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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