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, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure more efficient and consistent regulatory review of submissions for these products. The guidance also provides recommendations to industry on how to comply with the applicable requirements. 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 equivalent IEC standards, as outlined in this guidance, to fulfill the requirements of the EPRC regulation. Using a declaration of conformity to equivalent IEC standards reduces duplication of efforts by manufacturers and allows FDA to provide more efficient and consistent regulatory reviews of submissions relating to medical x-ray imaging devices.