Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

The Device Development Process


Device Discovery and Concept

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


FDA Post-Market Safety Monitoring

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