CDRH Industry: FDA Draft Guidance - Medical X-Ray Imaging Devices Conformance with IEC Standards

Today, the U.S. Food and Drug Administration announced the availability of the draft guidance titled "Medical X-Ray Imaging Devices Conformance with IEC Standards".

This draft guidance describes FDA’s policy regarding the regulation of medical x-ray imaging equipment that are subject to requirements in the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA regulations that apply to medical devices and electronic products.  In this draft guidance, FDA is seeking to harmonize the FDA electronic product radiation control (EPRC) performance standards with the International Electrotechnical Commission (IEC) standards, where appropriate, to streamline regulatory review of submissions for these products.

Comments to this draft guidance should be submitted either electronically or in writing within 90 days of the draft guidance publishing in the FEDERAL REGISTER.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health