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

S

sokku

Hello

Can anyone share or update the step by step process flow chart of US FDA PMA approval process?..
 
Ajit Basrur

Ajit Basrur

Leader
Admin
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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