Final Guidance: Regulations of Diagnostic X-Ray Equipment

U.S. Food and Drug Administration sent this bulletin at 09/27/2024 09:12 AM EDT

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U.S. Food and Drug Administration, Center for Devices and Radiological Health

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.

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