An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: MRI (Magnetic Resonance Imaging)

The FDA's Role

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices and the safety of radiation-emitting electronic products. The FDA regulates firms that manufacture, repackage, re-label, and/or import these products, including MRI equipment, sold in the United States. Other federal and state agencies regulate the use of MRI devices through determining MRI personnel qualifications, developing institutional quality assurance programs, and conducting facility accreditation. MRI scanners are Class II (moderate risk) medical devices, meaning that an MRI manufacturer is required to submit a Premarket Notification 510(k) prior to marketing their MRI System.

Top