United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2023_register executive 2023-01-20 article Rules and Regulations D09002ee1c79fa0d5 D09002ee1c79fa90b United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, Agency, or we) is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. 88 FR 3638 https://www.govinfo.gov/app/details/FR-2023-01-20/2023-00922 2023-00922 fr20ja23-5 RIN 0910-AH65 4164-01-P Docket No. FDA-2018-N-3303 https://www.govinfo.gov/app/details/FR-2023-01-20/2023-00922 https://www.govinfo.gov/content/pkg/FR-2023-01-20/html/2023-00922.htm https://www.govinfo.gov/content/pkg/FR-2023-01-20/pdf/2023-00922.pdf Electronic Products Radiation Protection Reporting and Recordkeeping Requirements X-Rays Administrative Practice and Procedure Exports Medical Devices Television Microwave Ovens 17 p. 3638 3654 88 FR 3638 Title 21 Part 1000 21 CFR Part 1000 Title 21 Part 1002 21 CFR Part 1002 Title 21 Part 1010 21 CFR Part 1010 Title 21 Part 1020 21 CFR Part 1020 Title 21 Part 1030 21 CFR Part 1030 Title 21 Part 1050 21 CFR Part 1050 RIN 0910-AH65 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; Federal Register Vol. 88, Issue RULE 2023-00922 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2023-02-21 Docket No. FDA-2018-N-3303 4164-01-P 2023-00922 Final rule.

The Food and Drug Administration (FDA, Agency, or we) is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.

This rule is effective February 21, 2023. Robert Ochs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3680, Silver Spring, MD 20993, 301-796-6661, email: Robert.Ochs@fda.hhs.gov. Electronic Products Radiation Protection Reporting and Recordkeeping Requirements X-Rays Administrative Practice and Procedure Exports Medical Devices Television Microwave Ovens Radiological Health: Records and Reports for Radiation Emitting Electronic Products; Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products, RadHealthCustomerService@fda.hhs.gov Robert.Ochs@fda.hhs.gov http://www.icrp.org/publication.asp?id=ICRP%20Publication%20103 https://cdn.ymaws.com/www.crcpd.org/resource/collection/81C6DB13-25B1-4118-8600-9615624818AA/E-19-2_2014-2015_Dental_NEXT_Summary_Report.pdf https://ncrponline.org/publications/reports/ncrp-report-168/ https://ncrponline.org/publications/reports/ncrp-reports-145/ https://ncrponline.org/shop/reports/report-no-177/ https://ncrponline.org/shop/reports/report-no-180-management-of-exposure-to-ionizing-radiation-radiation-protection-guidance-for-the-united-states-2018-2018/ https://webstore.iec.ch/publication/2098 https://www.acr.org/Quality-Safety/Appropriateness-Criteria https://www.epa.gov/sites/production/files/2015-05/documents/fgr14-2014.pdf https://www.fda.gov/about-fda/reports-manuals-forms/forms https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Radiation-EmittingProducts/TechnicalElectronicProductRadiationSafetyStandardsCommittee/ucm526004.htm https://www.fda.gov/industry/import-program-food-and-drug-administration-fda https://www.fda.gov/media/114034/download https://www.fda.gov/media/84818/download https://www.fda.gov/media/99466/download https://www.fda.gov/radiation-emitting-products/initiative-reduce-unnecessary-radiation-exposure-medical-imaging/white-paper-initiative-reduce-unnecessary-radiation-exposure-medical-imaging#:∼:text=practicing%20medical%20community.-,Initiative%20to%20Reduce%20Unnecessary%20Radiation%20Exposure%20from%20Medical%20Imaging,CT%2C%20fluoroscopy%2C%20and%20nuclear%20medicine https://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/default.htm https://www.federalregister.gov/documents/2016/01/27/2016-01606/revision-of-omb-circular-no-a-119-federal-participation-in-the-development-and-use-of-voluntary https://www.regulations.gov www.ncrponline.org Vol. 88, no. 13 Office of the Federal Register, National Archives and Records Administration 2023-01-20 continuing daily deposited born digital 289 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-01-20 P0b002ee1bbb8f53c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20ja23 https://www.govinfo.gov/app/details/FR-2023-01-20 https://www.govinfo.gov/content/pkg/FR-2023-01-20/pdf/FR-2023-01-20.pdf https://www.govinfo.gov/content/pkg/FR-2023-01-20/xml/FR-2023-01-20.xml fdlp 3629 3909 DGPO 2023-01-20 2024-05-29 FR-2023-01-20 machine generated eng FR FR-2023-01-20 88 13