{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act.","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/2021/04/19/2021-07860.html","cfr_references":[{"chapter":null,"citation_url":null,"part":862,"title":21},{"chapter":null,"citation_url":null,"part":866,"title":21},{"chapter":null,"citation_url":null,"part":880,"title":21},{"chapter":null,"citation_url":null,"part":884,"title":21},{"chapter":null,"citation_url":null,"part":892,"title":21}],"citation":"86 FR 20278","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective on April 19, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-1440"],"dockets":[],"document_number":"2021-07860","effective_on":"2021-04-19","end_page":20284,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/04/19/2021-07860.xml","html_url":"https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-07860?publication_date=2021-04-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-04-19/2021-07860/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":18883,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-19/pdf/2021-07860.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-07860.pdf?1618577122","publication_date":"2021-04-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/04/19/2021-07860.txt","regulation_id_number_info":{"0910-AH67":{"issue":"202010","html_url":"https://www.federalregister.gov/regulations/0910-AH67/medical-devices-amendments-to-medical-device-classification-regulations-to-conform-to-medical-softwa","title":"Medical Devices; Amendments to Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202010&RIN=0910-AH67&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH67"],"regulations_dot_gov_info":{"supporting_documents":[],"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-1440","supporting_documents_count":0,"docket_id":"FDA-2018-N-1440","document_id":"FDA-2018-N-1440-0001","regulation_id_number":null,"title":"Medical Devices; Amendment and Repeals to Medicals Device Software Regulations","checked_regulationsdotgov_at":"2021-04-20T03:30:10Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":20278,"subtype":null,"title":"Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act","toc_doc":"Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act","toc_subject":"Medical Devices:\n","topics":["Biologics","Laboratories","Medical devices","Radiation protection","X-rays"],"type":"Rule","volume":86}