FDA draft guidance addresses radiation rules for diagnostic x-ray manufacturers

The FDA issued a draft guidance on Monday, Dec. 17 in an effort to clarify radiation regulations to manufacturers of diagnostic x-ray systems.  

When finalized, the draft will supersede the guidance first issued on the subject in 1989 by the FDA, entitled the “Clarification of Radiation Control Regulations for Diagnostic X-ray Equipment."

The agency also stated in the guidance that such manufacturers should be aware that the FDA’s Center for Devices and Radiological Health (CDRH) intends to amend its performance standards to harmonize requirements with those of the International Electrotechnical Commission to simplify compliance for global manufacturers.  

“Manufacturers are advised to regularly check the FDA website for new developments on this topic,” according to the guidance.  

Under its performance standards, the FDA said manufacturers of diagnostic x-ray equipment must:  

  • Certify that each component complies with the applicable performance standards

  • Permanently inscribe or affix certification and identification labels on the component or system (as applicable) complete with the name and address of the manufacturer, date and place of manufacture, model designation and serial number of each component

  • Provide the assembler and others who request it—at a cost not to exceed the cost of publication and distribution—with adequate instructions for assembly, installation, adjustment and testing of components to assure they comply with the Performance Standards when instructions are followed

  • Provide the purchaser with adequate instructions describing technical specifications for the equipment, any radiological safety precautions and procedures necessary due to unique features of the equipment, and a maintenance schedule to ensure the equipment is following performance standards.

Additional information on requirements for assemblers of x-ray systems can be found here. The FDA is welcoming comments and suggestions on the documents for the next 60 days and may be submitted here.