The U.S. FDA has 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.
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.
According to the FDA, the X-ray guidance describes the organization’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 International Electrotechnical Commission standards would provide.