Zdrowie i gospodarka · 08/05/2019

FDA Releases Final Guidance on Medical X-Ray Imaging Devices Conformance with IEC Standards

The Food and Drug Administration (FDA) has released a final guidance document outlining its policy on the regulation of medical x-ray imaging devices that meet International Electrotechnical Commission (IEC) standards. The guidance is intended for industry professionals and FDA staff, and provides clarity on FDA's approach to regulating these devices.