Radiological Health Regulations; Technical Amendments

Document 2025-18080 is a Final Rule published by the Food and Drug Administration in the Federal Register on September 18, 2025, with an effective date of September 18, 2025. The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text. View the original at https://www.federalregister.gov/documents/2025/09/18/2025-18080/radiological-health-regulations-technical-amendments.

No. Document 2025-18080 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.