{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of four final device-specific guidance documents for the Safety and Performance Based Pathway--specifically, \"Air Powered Dental Handpieces and Air Motors--Performance Criteria for Safety and Performance Based Pathway,\" \"Dental Ceramics--Performance Criteria for Safety and Performance Based Pathway,\" \"Dental Impression Materials--Performance Criteria for Safety and Performance Based Pathway,\" and \"Dental Cements--Performance Criteria for Safety and Performance Based Pathway.\" The device-specific guidances identified in this notice were developed in accordance with the finalized 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/2024/09/30/2024-22309.html","cfr_references":[],"citation":"89 FR 79615","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidances is published in the Federal Register on September 30, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-D-4168","FDA-2024-D-4169","FDA-2024-D-4170","and FDA-2024-D-4171"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-09-30T11:56:07.443-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-4168-0001","allow_late_comments":false,"id":"FDA-2024-D-4168-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-4168","title":"Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability; Air Powered Dental Handpieces and Air Motors--Performance Criteria for Safety and Performance Based Pathway"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-09-30T11:56:09.491-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-4169-0001","allow_late_comments":false,"id":"FDA-2024-D-4169-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-4169","title":"Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability; Dental Ceramics -- Performance Criteria for Safety and Performance Based Pathway"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-09-30T11:56:06.002-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-4170-0001","allow_late_comments":false,"id":"FDA-2024-D-4170-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-4170","title":"Safety and Performance Based Pathway Device-Specific Guidances; 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