United States Issues Guidance on Conformity of Medical X-Ray Devices with International Standards

July 18, 2019


On May 8, 2019, the US Food and Drug Administration (FDA) has issued two final guidance documents regarding X-ray devices designed to more closely align FDA requirements with internationally developed standards:


  • The Guidance “Policy Clarification for Certain Fluoroscopic Equipment Requirements”


This guidance covers standards for fluoroscopic equipment, clarifying aspects of US performance requirements: fluoroscopic irradiation time, last image hold, and emergency fluoroscopy mode. The draft guidance was issued in September 2014.


  • The Guidance “Medical X-Ray Imaging Devices Conformance with IEC Standards”


The final guidance updates the draft policy issued in August 2016.


This Guidance describes FDA’s policy regarding the regulation of medical X-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products. 


In this Guidance, the FDA is seeking to harmonize performance standards prescribed by Electronic Product Radiation Control (EPRC) of the FD&C Act with IEC standards. 


The Guidance also provides recommendations to industry on how to comply with the applicable requirements. The FDA has determined that industry conformance to 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.

Manufacturers and importers of medical X-ray imaging equipment must follow the current EPRC regulations and procedures or provide a declaration of conformity to the equivalent IEC standards, as outlined in this Guidance, to fulfill the requirements of the EPRC regulation. Using a declaration of conformity to the equivalent IEC standards reduces duplication of efforts by manufacturers and allows the FDA to provide more efficient and consistent regulatory reviews of submissions relating to medical X-ray imaging devices.


Links to the official documents:

The information has been prepared by the GMA Consult Group team.


GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.


Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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