FDA issues Two Final Guidances on Medical X-ray Imaging Devices

Today, the U.S., Food and Drug Administration (FDA) issued two final guidances that better align current FDA regulatory requirements for x-ray imaging with international consensus standards. The first guidance, Medical X-Ray Imaging Devices Conformance with IEC Standards Final Guidance, describes the FDA’s policy regarding the role of IEC standards in the regulation of medical x-ray imaging equipment that is subject to requirements in the Federal Food, Drug & Cosmetic Act (FD&C Act) and the FDA’s medical device and electronic product regulations.

Read the Medical X-Ray Imaging Final Guidance

The other final guidance, Policy Clarification for Certain Fluoroscopic Equipment Requirements Final Guidance, which clarifies how manufacturers can comply with the FDA’s fluoroscopic equipment performance standard requirements in 21 CFR 1020.32. Read the Fluoroscopic Equipment Final Guidance Questions? If you have questions about either of these final guidances, contact the Division of Industry and Consumer Education.