Zdrowie i gospodarka · 08/05/2019
Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Medical X- Ray Imaging Devices Conformance with IEC Standards." This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products.