Centers for Devices and Radiological Health (CDRH)

What is the CDRH?

The Centers for Devices and Radiological Health (CDRH) is a branch of the Food and Drug Administration (FDA) that ensures patients and providers have timely and continued access to safe radiation-emitting products and medical devices that are safe, effective, and high-quality.

The Bureau of Medical Devices was established as a branch of the FDA in 1973, and in 1982 it was merged with the Bureau of Radiological Health, forming the CDRH.

Why is the CDRH important for healthcare?

The CDRH plays an essential role in ensuring that the medical devices used by patients are safe and effective. They apply general controls to the devices such as registration, labeling, listing, and repair/replace/refund requirements.

The CDRH develops performance standards for Class II devices, and for Class III devices, the CDRH completes premarket approvals. This branch also oversees the manufacturing, performance, and safety of these devices.

Another essential covering of the CDRH is radiation-emitting devices and products. They develop performance standards and guidelines for these devices to prevent unnecessary radiation exposure.

Overall, the CDRH plays an important role in ensuring the safety and effectiveness of medical devices, assuring consumers that the medical devices they use will offer the stated benefits without causing unnecessary harm.