Center for Devices and Radiological Health (CDRH)
The Center for Devices and Radiological Health (CDRH) is the FDA division responsible for regulating medical devices and radiation-emitting products. It reviews premarket submissions, oversees post-market safety, and sets standards that device manufacturers must meet to market products in the United States.
What is the Center for Devices and Radiological Health (CDRH)?
The Center for Devices and Radiological Health (CDRH) is the division of the U.S. Food and Drug Administration that regulates medical devices and products that emit radiation, such as imaging equipment. It is responsible for ensuring these products are reasonably safe and effective for their intended use.
CDRH reviews premarket submissions from manufacturers, monitors device safety once products are in use, and establishes the standards that companies must meet to market devices in the United States. Its oversight spans the full range of devices, from simple instruments to complex implantable technology.
Why does CDRH matter for device manufacturers?
For medical device manufacturers, the Center for Devices and Radiological Health (CDRH) is the gatekeeper to the U.S. market, since its premarket review determines whether a device may be sold. Meeting its requirements is a necessary step before commercialization.
Beyond initial review, CDRH's post-market oversight and standard-setting shape how devices are monitored and maintained in the field. Manufacturers must account for the center's expectations throughout a product's lifecycle, not just at launch.
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