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  4. The Device Development Process
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The Device Development Process

 
Device Discovery and Concept
Research for a new drug or device begins in the laboratory.
 
Preclinical Research–Prototype
Devices undergo laboratory and animal testing to answer basic questions about safety.
 
Pathway to Approval
Devices are tested on people to make sure they are safe and effective.
 
FDA Review
FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
 
FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.