The FDA announces an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy.

“The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Through the FDA’s regulatory oversight of medical imaging devices and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

The three-pronged FDA initiative will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30 and 31 to solicit input on what requirements to establish.

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