{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of three device-specific final guidance documents for the Safety and Performance Based Pathway--specifically, \"Spinal Plating Systems--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,\" \"Orthopedic Non-Spinal Metallic Bone Screws and Washers-- Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,\" and \"Magnetic Resonance (MR) Receive-only Coil--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.\" The device-specific guidances identified in this notice were developed in accordance with the final guidance entitled \"Safety and Performance Based Pathway.\"","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/2020/12/11/2020-27248.html","cfr_references":[],"citation":"85 FR 80114","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidances is published in the Federal Register on December 11, 2020.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2019-D-1647, FDA-2019-D-1652, and FDA-2019-D-1650"],"dockets":[],"document_number":"2020-27248","effective_on":null,"end_page":80116,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/12/11/2020-27248.xml","html_url":"https://www.federalregister.gov/documents/2020/12/11/2020-27248/performance-criteria-for-safety-and-performance-based-pathway-guidances-for-industry-and-food-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-27248?publication_date=2020-12-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-12-11/2020-27248/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":821,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-12-11/pdf/2020-27248.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-27248.pdf?1607607942","publication_date":"2020-12-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/12/11/2020-27248.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-1647","supporting_documents_count":0,"docket_id":"FDA-2019-D-1647","document_id":"FDA-2019-D-1647-0005","regulation_id_number":null,"title":"Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff","checked_regulationsdotgov_at":"2020-12-14T04:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":80114,"subtype":null,"title":"Performance Criteria for Safety and Performance Based Pathway; Guidances for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Performance Criteria for Safety and Performance Based Pathway","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}