{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff.\" This draft guidance articulates FDA's current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability to populations within the United States and study design issues and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards to support approval or clearance of the device in the United States. This guidance is not intended to announce new policy, but to describe FDA's existing approach to this topic. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2015/04/21/2015-09176.html","cfr_references":[],"citation":"80 FR 22205","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 20, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-0975"],"dockets":[],"document_number":"2015-09176","effective_on":null,"end_page":22206,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/04/21/2015-09176.xml","html_url":"https://www.federalregister.gov/documents/2015/04/21/2015-09176/acceptance-of-medical-device-clinical-data-from-studies-conducted-outside-the-united-states-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-09176?publication_date=2015-04-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-04-21/2015-09176/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":992,"last_updated":"2026-04-05 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-04-21/pdf/2015-09176.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-09176.pdf?1429533994","publication_date":"2015-04-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/04/21/2015-09176.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-2015-D-0975","supporting_documents_count":0,"docket_id":"FDA-2015-D-0975","regulation_id_number":null,"title":"Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States","checked_regulationsdotgov_at":"2015-07-21T05:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":22205,"subtype":null,"title":"Acceptance of Medical Device Clinical Data From Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}