Radiological Health Amendments for Diagnostic X-ray, Laser Products and Ultrasonic Products – Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a proposed rule, "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser Products and Ultrasonic Products." The proposed rule amends parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain reporting and records of electronic products and accidental radiation occurrences, and performance standards of diagnostic x-ray systems, laser products, and ultrasonic therapy products.

We are taking this action to update the regulations to reduce unnecessary regulatory requirements that are outdated or duplicate other equally effective means for protecting the public health and safety against exposure to radiation emitting electronic products.

Comments to this proposed rule should be submitted either electronically or in writing within 90 days of the rule publishing in the Federal Register. The FDA will consider all comments received to the Docket in finalizing this rule. The amendments in the proposed rule must be published as a final rule before they can take effect. 

Food and Drug Administration

Center for Devices and Radiological Health