Center for Devices and Radiological Health (CDRH)
What is the Center for Devices and Radiological Health (CDRH)?
The Center for Devices and Radiological Health (CDRH) works under the U.S. Food and Drug Administration (FDA) and ensures the safety and efficacy of medical devices and radiation-emitting products.
One of the tasks of the CDRH is to apply general controls for medical devices, such as registration, labeling, good manufacturing practices, listing, and requirements for repairing/replacing/refunding. The CDRH also conducts premarket reviews of new devices.
The CDRH is responsible for classifying each device type into an appropriate regulatory control category:
- Class I devices: require only general controls
- Class II devices: require standards
- Class III devices: require premarket approval
As for radiation-emitting products and devices, the CDRH has developed guidelines and performance standards to prevent unnecessary radiation exposure to those using these devices.
Why is the Center for Devices and Radiological Health (CDRH) important for healthcare?
The Center for Devices and Radiological Health (CDRH) aims to encourage the discovery and development of new medical devices while protecting the rights and safety of those who use them. The CDRH holds medical devices to certain standards and requires proof of their safety before allowing their distribution.
The Center for Devices and Radiological Health also emphasizes transparency in medical devices, allowing everyone access to proof of the device’s safety and efficacy, increasing consumer confidence in medical devices marketed in the U.S.
Overall, the CDRH plays a crucial role in upholding medical device safety and efficacy.