{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Molecular Diagnostic Instruments with Combined Functions.\" This guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.","action":"Notice.","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/2014/11/12/2014-26694.html","cfr_references":[],"citation":"79 FR 67175","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0258"],"dockets":[],"document_number":"2014-26694","effective_on":null,"end_page":67176,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/11/12/2014-26694.xml","html_url":"https://www.federalregister.gov/documents/2014/11/12/2014-26694/combined-functionality-for-molecular-diagnostic-instruments-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-26694?publication_date=2014-11-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-11-12/2014-26694/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":164,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-11-12/pdf/2014-26694.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-26694.pdf?1415627957","publication_date":"2014-11-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/11/12/2014-26694.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-2013-D-0258","supporting_documents_count":0,"docket_id":"FDA-2013-D-0258","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Combined Functionality for Molecular Diagnostic Instruments; Availability","checked_regulationsdotgov_at":"2015-01-12T19:17:45Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67175,"subtype":null,"title":"Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Combined Functionality for Molecular Diagnostic Instruments","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}