The U.S. Food and Drug Administration (FDA) has issued two final guidances that outline regulatory requirements for x-ray imaging.
The first guidance, "Medical X-Ray Imaging Devices Conformance with IEC Standards Final Guidance," describes the agency's policy regarding the role of International Electrotechnical Commission (IEC) standards in regulating medical x-ray imaging equipment subject to requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA's medical device and electronic product regulations.
The second document, "Policy Clarification for Certain Fluoroscopic Equipment Requirements Final Guidance," describes how manufacturers can comply with the agency's fluoroscopic equipment performance standard requirements in 21 Code of Federal Regulations 1020.32.
