CENTER FOR DEVICE AND RADIOLOGICAL HEALTH (CDRH)

The CDRH is the center in the FDA responsible for the following:

  • Issuing approval of the Investigational Device Exemption(s) before the manufacturer initiates a clinical device investigation (human trials);


  • Classifying medical devices;


  • Review and issuance of marketing clearance/approval of devices;


  • Post-marketing surveillance of approved devices.

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