A new draft guidance from the FDA aims to clarify the agency’s policies concerning the production of diagnostic x-ray systems. The guidance, “Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment,” once finalized, would replace the FDA’s previous guidance on this issue from 1989.
Device manufacturers, according to the document, are required to ensure all equipment complies with applicable standards, permanently apply certification and identification labels, provide “adequate” assembly and installation instructions and provide documentation that describes “specific technical specifications of the equipment and any necessary radiological safety precautions and procedures which may be necessary.”
The guidance also covers several “specific topics of importance” for manufacturers of these devices, including certification, labeling, measurements and more. Information is provided in a “question and answer” format.
The FDA’s Center for Devices and Radiological Health (CDRH) is tasked with enforcing these regulations.
“Manufacturers of diagnostic x-ray systems should be aware that CDRH intends to amend FDA’s Performance Standards, as appropriate, to harmonize many of its requirements with those of the International Electrotechnical Commission (IEC) standards because FDA acknowledges the importance of simplifying compliance for global manufacturers,” according to the guidance. “Manufacturers are advised to regularly check the FDA website for new developments on this topic.”
The FDA is accepting electronic and written comments on this guidance until Feb. 15, 2019.