FDA Issues Guidance on Medical X-Ray Devices and Conformity with IEC Standards

The U.S. Food and Drug Administration (FDA) has issued a guidance that addresses comparable disparities in the regulations applicable to medical x-ray devices.

The guidance, “Medical X-Ray Imaging Devices Conformance with IEC Standards,” seeks to harmonize performance requirements found in the Electronic Radiation Control (EPRC) subchapter of the U.S. Federal Food, Drug & Cosmetic Act (FD&C) with the requirements stipulated in relevant IEC standards. Noting that “industry conformance with certain IEC standards would provide, at a minimum, the same level of protection of the public health and safety from electronic radiation as certain EPRC regulatory standards,” the guidance goes on to provide specific details on how manufacturers can meet the EPRC requirements by demonstrating conformity with the appropriate sections of the IEC standards.

Read the complete text of the FDA’s guidance on medical x-ray devices.

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