Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

The Device Development Process

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Device Discovery and Concept

Research for a new 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 device and make a decision to approve or not to approve it.

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FDA Post-Market Safety Monitoring

FDA monitors all device safety once products are available for use by the public.