{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.' \" FDA has developed this guidance document to assist industry in preparing premarket applications (PMAs), humanitarian device exemptions (HDEs), investigational device applications (IDEs), premarket notifications (510(k)s), and de novo requests for medical devices that come into direct or indirect contact with the human body in order to determine the potential toxicity resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of the Office of Device Evaluation (ODE) General Program Memorandum <greek-i>G95-1 entitled \"Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,' \" dated May 1, 1995. When final, this guidance will therefore replace <greek-i>G95-1. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human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/2013/04/23/2013-09479.html","cfr_references":[],"citation":"78 FR 23940","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 22, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0350"],"dockets":[],"document_number":"2013-09479","effective_on":null,"end_page":23941,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/04/23/2013-09479.xml","html_url":"https://www.federalregister.gov/documents/2013/04/23/2013-09479/use-of-international-standard-iso-10993-biological-evaluation-of-medical-devices-part-1-evaluation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-09479?publication_date=2013-04-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-04-23/2013-09479/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2374,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-04-23/pdf/2013-09479.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-09479.pdf?1366635289","publication_date":"2013-04-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/04/23/2013-09479.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-0350","supporting_documents_count":0,"docket_id":"FDA-2013-D-0350","regulation_id_number":null,"title":"Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part1: Evaluation and Testing”; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2013-05-26T05:01:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23940,"subtype":null,"title":"Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing”; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Use of International Standard ISO10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing","toc_subject":"Draft Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":78}