FDA Issues Final Guidance on Regulations Governing Diagnostic X-Ray Equipment
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.