{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.\" This guidance, developed by the Oncology Center of Excellence at FDA, describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements. In the streamlined process, the sponsor submits all information about the oncology trial (including information about the investigational in vitro diagnostic) to the investigational new drug application (IND). As part of IND review, the Center for Biologics Evaluation and Research (CBER) works with the Center for Drug Evaluation and Research (CDER), or CDER or CBER works with the Center for Devices and Radiological Health (CDRH), as appropriate, to determine if the investigational in vitro diagnostic is significant risk, nonsignificant risk, or exempt.","action":"Notice of availability.","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/2019/10/10/2019-22117.html","cfr_references":[],"citation":"84 FR 54613","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 10, 2019.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-0944"],"dockets":[],"document_number":"2019-22117","effective_on":null,"end_page":54615,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2019/10/10/2019-22117.xml","html_url":"https://www.federalregister.gov/documents/2019/10/10/2019-22117/investigational-in-vitro-diagnostics-in-oncology-trials-streamlined-submission-process-for-study","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2019-22117?publication_date=2019-10-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2019-10-10/2019-22117/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":554,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-10-10/pdf/2019-22117.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-22117.pdf?1570625119","publication_date":"2019-10-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2019/10/10/2019-22117.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-2018-D-0944","supporting_documents_count":0,"docket_id":"FDA-2018-D-0944","regulation_id_number":null,"title":"Investigational In Vitro Diagnostics in Oncology Trials:  Streamlined Submission Process for Study Risk Determination","checked_regulationsdotgov_at":"2019-10-13T03:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":54613,"subtype":null,"title":"Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry; Availability","toc_doc":"Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":84}