{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry entitled \"Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns.\" FDA has received many inquiries pertaining to multiplex test submissions (including microarray submissions). This draft guidance document represents the Center for Devices and Radiological Health's (CDRH) attempt to continue the dialogue with stakeholders regarding the basic framework for the types of data that should be included in a submission. FDA is anxious to provide the best guidance possible to assist sponsors in developing multiplex text submissions that will support timely review and marketing of safe and effective products using this technology. This draft guidance document is neither final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2003/04/21/03-9661.html","cfr_references":[],"citation":"68 FR 19549","comment_url":null,"comments_close_on":"2003-07-21","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on this draft guidance document by July 21, 2003.","disposition_notes":null,"docket_ids":["Docket No. 03D-0120"],"dockets":[],"document_number":"03-9661","effective_on":null,"end_page":19550,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/04/21/03-9661.xml","html_url":"https://www.federalregister.gov/documents/2003/04/21/03-9661/medical-devices-draft-guidance-for-industry-and-fda-reviewers-multiplex-tests-for-heritable-dna","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-9661?publication_date=2003-04-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-04-21/03-9661/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":48,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-04-21/pdf/03-9661.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-04-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/04/21/03-9661.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19549,"subtype":null,"title":"Medical Devices: Draft Guidance for Industry and FDA Reviewers; Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns; Availability","toc_doc":"Multiplex tests for heritable DNA markers, mutations, and expression patterns","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}