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  4. The Device Development Process
  1. Learn About Drug and Device Approvals

The Device Development Process

Device Discovery and Concept
Research for a new drug or device begins in the laboratory.
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Preclinical Research–Prototype
Devices undergo laboratory and animal testing to answer basic questions about safety.
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Pathway to Approval
Devices are tested on people to make sure they are safe and effective.
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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.
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FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.
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