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.