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 In this section:

                The Device Development Process

The Device Development Process

                        Step 1: Device Discovery and Concept
          Step 2: Preclinical Research-Prototype
          Step 3: Pathway to Approval
          Step 4: FDA Device Review
          Step 5: FDA Post-Market Device Safety Monitoring Home
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          Learn About Drug and Device Approvals
          The Device Development Process
          Step 2: Preclinical Research-PrototypeThe Device Development Process Step 2: Preclinical Research-Prototype
  
  	
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    PrintResearchers build a device prototype, or an early version of a medical device. At this stage, the device prototype is not for human use. Researchers test the prototypes in controlled laboratory settings. Refining the prototype provides researchers with important information about the product’s potential use for people. The prototype process attempts to reduce risk of harm in people. However, it is not possible to eliminate risk entirely.

                                                                                  Content current as of:
      01/04/2018The Device Development Process

          
                        Step 1: Device Discovery and Concept
          Step 2: Preclinical Research-Prototype
          Step 3: Pathway to Approval
          Step 4: FDA Device Review
          Step 5: FDA Post-Market Device Safety Monitoring
 
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