{"abstract":"The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the Assisted Reproduction Embryo Image Assessment System classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"Final order.","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/2015/02/26/2015-03934.html","cfr_references":[{"chapter":null,"citation_url":null,"part":884,"title":21}],"citation":"80 FR 10330","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective February 26, 2015. The classification was applicable June 6, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-M-1957"],"dockets":[],"document_number":"2015-03934","effective_on":"2015-02-26","end_page":10333,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/26/2015-03934.xml","html_url":"https://www.federalregister.gov/documents/2015/02/26/2015-03934/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-assisted-reproduction","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-03934?publication_date=2015-02-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-26/2015-03934/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":460,"last_updated":"2026-10-24 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-26/pdf/2015-03934.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-03934.pdf?1424872169","publication_date":"2015-02-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/26/2015-03934.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 K120427 De Novo Request from Auxogyn, Inc, dated August 23, 2012 re Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System, FDA-2014-M-1957-0001","document_id":"FDA-2014-M-1957-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-M-1957","supporting_documents_count":1,"docket_id":"FDA-2014-M-1957","regulation_id_number":null,"title":"Classification of the Assisted Reproduction Embryo Image Assessment System","checked_regulationsdotgov_at":"2015-03-18T06:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10330,"subtype":null,"title":"Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System","toc_doc":"Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":80}