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.