{"abstract":"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 The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/01/20/2023-00922.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1000","title":21},{"chapter":null,"citation_url":null,"part":"1002","title":21},{"chapter":null,"citation_url":null,"part":"1010","title":21},{"chapter":null,"citation_url":null,"part":"1020","title":21},{"chapter":null,"citation_url":null,"part":"1030","title":21},{"chapter":null,"citation_url":null,"part":"1050","title":21}],"citation":"88 FR 3638","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective February 21, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-3303"],"dockets":[{"supporting_documents":[{"title":"Reference 15 - NCRP Report 160","document_id":"FDA-2018-N-3303-0013"},{"title":"Reference 12 - NCRP Report 172","document_id":"FDA-2018-N-3303-0012"},{"title":"Reference 11 - ICRP Radiological Protection in Medicine Pub. 105","document_id":"FDA-2018-N-3303-0011"},{"title":"Reference 9 - NCRP Report 168","document_id":"FDA-2018-N-3303-0010"},{"title":"Reference 6 - CRCPD, “Part F-Medical Diagnostic and Interventional X-ray Imaging and Systems 2015","document_id":"FDA-2018-N-3303-0009"},{"title":"Reference 5 - ADA Dental Radiographic Examinations 2012","document_id":"FDA-2018-N-3303-0008"},{"title":"Reference 4 - NCRP Report No 145","document_id":"FDA-2018-N-3303-0007"},{"title":"Reference 3 - EPA Report No 14_ Radiation Protection Guidance","document_id":"FDA-2018-N-3303-0006"},{"title":"Rad Health PR PRIA FINAL VERSION","document_id":"FDA-2018-N-3303-0005"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-01-20","updated_at":"2023-02-24T21:54:37.100-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-N-3303-0022","allow_late_comments":null,"id":"FDA-2018-N-3303-0022","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":9,"id":"FDA-2018-N-3303","title":"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  (proposed rule)"}],"document_number":"2023-00922","effective_on":"2023-02-21","end_page":3654,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/01/20/2023-00922.xml","html_url":"https://www.federalregister.gov/documents/2023/01/20/2023-00922/radiological-health-regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-00922?publication_date=2023-01-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-01-20/2023-00922/mods.xml","not_received_for_publication":null,"page_length":17,"page_views":{"count":14681,"last_updated":"2026-06-14 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-01-20/pdf/2023-00922.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-00922.pdf?1674135915","publication_date":"2023-01-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/01/20/2023-00922.txt","regulation_id_number_info":{"0910-AH65":{"issue":"202210","html_url":"https://www.federalregister.gov/regulations/0910-AH65/radiological-health-regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic-","title":"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","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AH65&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH65"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 15 - NCRP Report 160","document_id":"FDA-2018-N-3303-0013"},{"title":"Reference 12 - NCRP Report 172","document_id":"FDA-2018-N-3303-0012"},{"title":"Reference 11 - ICRP Radiological Protection in Medicine Pub. 105","document_id":"FDA-2018-N-3303-0011"},{"title":"Reference 9 - NCRP Report 168","document_id":"FDA-2018-N-3303-0010"},{"title":"Reference 6 - CRCPD, “Part F-Medical Diagnostic and Interventional X-ray Imaging and Systems 2015","document_id":"FDA-2018-N-3303-0009"},{"title":"Reference 5 - ADA Dental Radiographic Examinations 2012","document_id":"FDA-2018-N-3303-0008"},{"title":"Reference 4 - NCRP Report No 145","document_id":"FDA-2018-N-3303-0007"},{"title":"Reference 3 - EPA Report No 14_ Radiation Protection Guidance","document_id":"FDA-2018-N-3303-0006"},{"title":"Rad Health PR PRIA FINAL VERSION","document_id":"FDA-2018-N-3303-0005"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AH65/radiological-health-regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic-","title":"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"},"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-3303","supporting_documents_count":9,"docket_id":"FDA-2018-N-3303","document_id":"FDA-2018-N-3303-0022","regulation_id_number":"0910-AH65","title":"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  (proposed rule)","checked_regulationsdotgov_at":"2023-05-05T16:00:15Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":3638,"subtype":null,"title":"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","toc_doc":"Records and Reports for Radiation Emitting Electronic Products; Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products","toc_subject":"Radiological Health:\n","topics":["Administrative practice and procedure","Electronic products","Exports","Medical devices","Microwave ovens","Radiation protection","Reporting and recordkeeping requirements","Television","X-rays"],"type":"Rule","volume":88}