{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.\" The Agency has developed this guidance to provide FDA's current thinking on technical considerations specific to devices using nitinol due to the unique properties of nitinol. This guidance document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol.","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/2020/10/15/2020-22877.html","cfr_references":[],"citation":"85 FR 65409","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on October 15, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-1261"],"dockets":[],"document_number":"2020-22877","effective_on":null,"end_page":65410,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/15/2020-22877.xml","html_url":"https://www.federalregister.gov/documents/2020/10/15/2020-22877/technical-considerations-for-non-clinical-assessment-of-medical-devices-containing-nitinol-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-22877?publication_date=2020-10-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-15/2020-22877/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":673,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-15/pdf/2020-22877.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-22877.pdf?1602679551","publication_date":"2020-10-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/15/2020-22877.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-1261","supporting_documents_count":0,"docket_id":"FDA-2019-D-1261","document_id":"FDA-2019-D-1261-0015","regulation_id_number":null,"title":"Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2020-10-18T08:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65409,"subtype":null,"title":"Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}