{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations. These revisions are necessary to reflect changes to the Agency's Center for Devices and Radiological Health's organizational structure, including the reorganization of its offices. The revisions replace references to the obsolete offices and positions with the current information, update the physical addresses for such offices, and correct inaccurate citations. In addition, as part of this effort we made other editorial non-substantive changes to correct other addresses, references, and citations, as appropriate. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.","action":"Final rule; technical amendments.","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/2020/04/02/2020-06354.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"5","title":21},{"chapter":null,"citation_url":null,"part":"801","title":21},{"chapter":null,"citation_url":null,"part":"803","title":21},{"chapter":null,"citation_url":null,"part":"807","title":21},{"chapter":null,"citation_url":null,"part":"814","title":21},{"chapter":null,"citation_url":null,"part":"820","title":21},{"chapter":null,"citation_url":null,"part":"821","title":21},{"chapter":null,"citation_url":null,"part":"822","title":21},{"chapter":null,"citation_url":null,"part":"830","title":21},{"chapter":null,"citation_url":null,"part":"860","title":21},{"chapter":null,"citation_url":null,"part":"884","title":21},{"chapter":null,"citation_url":null,"part":"900","title":21},{"chapter":null,"citation_url":null,"part":"1002","title":21}],"citation":"85 FR 18439","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective April 1, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-0011"],"dockets":[],"document_number":"2020-06354","effective_on":"2020-04-01","end_page":18444,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/04/02/2020-06354.xml","html_url":"https://www.federalregister.gov/documents/2020/04/02/2020-06354/medical-devices-technical-amendments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-06354?publication_date=2020-04-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-04-02/2020-06354/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":6014,"last_updated":"2026-09-21 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-04-02/pdf/2020-06354.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-06354.pdf?1585745132","publication_date":"2020-04-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/04/02/2020-06354.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-0011","supporting_documents_count":0,"docket_id":"FDA-2020-N-0011","regulation_id_number":null,"title":"Technical Amendment (Unrelated to existing docket number)","checked_regulationsdotgov_at":"2020-04-05T03:30:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":18439,"subtype":null,"title":"Medical Devices; Technical Amendments","toc_doc":null,"toc_subject":null,"topics":["Administrative practice and procedure","Authority delegations (Government agencies)","Confidential business information","Electronic products","Health facilities","Imports","Labeling","Medical devices","Medical research","Organization and functions (Government agencies)","Radiation protection","Reporting and recordkeeping requirements","X-rays"],"type":"Rule","volume":85}