Per the notice below, the United States Food and Drug Administration (FDA) has issued a final guidance on regulations governing diagnostic x-ray equipment.

Clarifications for Manufacturers of Regulations for Diagnostic X-Ray Equipment.

Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.  This guidance provides clarification to device manufacturers and the FDA’s staff on the Federal Regulations related to diagnostic X-ray equipment.

Read the Guidance

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.