{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Assay Migration Studies for In Vitro Diagnostic Devices.\" This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for which the assay has not been previously approved, licensed, or cleared.","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/2013/04/25/2013-09759.html","cfr_references":[],"citation":"78 FR 24425","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-2008-D-0642"],"dockets":[],"document_number":"2013-09759","effective_on":null,"end_page":24426,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/04/25/2013-09759.xml","html_url":"https://www.federalregister.gov/documents/2013/04/25/2013-09759/assay-migration-studies-for-in-vitro-diagnostic-devices-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-09759?publication_date=2013-04-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-04-25/2013-09759/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":268,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-25/pdf/2013-09759.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-09759.pdf?1366808035","publication_date":"2013-04-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/04/25/2013-09759.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-2008-D-0642","supporting_documents_count":0,"docket_id":"FDA-2008-D-0642","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic Devices; Availability","checked_regulationsdotgov_at":"2013-05-15T08:05:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24425,"subtype":null,"title":"Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Assay Migration Studies for In Vitro Diagnostic Devices","toc_subject":"Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":78}