{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled \"Use of International Standard ISO 10993-1, `Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process.' \" FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response 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 International Standard ISO 10993- 1, \"Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process\" to support applications to FDA. This guidance supersedes Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled \"Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing.' \"","action":"Notice of availability.","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/2016/06/16/2016-14190.html","cfr_references":[],"citation":"81 FR 39269","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-0350"],"dockets":[],"document_number":"2016-14190","effective_on":null,"end_page":39271,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/16/2016-14190.xml","html_url":"https://www.federalregister.gov/documents/2016/06/16/2016-14190/use-of-international-standard-iso-10993-1-biological-evaluation-of-medical-devices-part-1-evaluation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-14190?publication_date=2016-06-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-16/2016-14190/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3093,"last_updated":"2026-04-03 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-16/pdf/2016-14190.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-14190.pdf?1465994758","publication_date":"2016-06-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/16/2016-14190.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":"2016-07-06T06:18:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":39269,"subtype":null,"title":"Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process”; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Use of International Standard ISO 109931, Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing Within a Risk Management Process","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":81}