{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of three final guidance documents for the Accreditation Scheme for Conformity Assessment Pilot Program-- specifically, \"The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff\"; \"Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff\"; and \"Biocompatibility Testing of Medical Devices--Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff.\" These guidances describe the goals, scope, procedures, and framework for the voluntary ASCA Pilot program, and provide information about two groups of consensus standards within the scope of the pilot program.","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/2020/09/25/2020-21234.html","cfr_references":[],"citation":"85 FR 60471","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of these guidances is published in the Federal Register on September 25, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-3805"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-09-25","updated_at":"2024-10-18T13:56:41.514-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-3805-0068","allow_late_comments":false,"id":"FDA-2019-D-3805-0068","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-3805","title":"The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability"}],"document_number":"2020-21234","effective_on":null,"end_page":60474,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/09/25/2020-21234.xml","html_url":"https://www.federalregister.gov/documents/2020/09/25/2020-21234/the-accreditation-scheme-for-conformity-assessment-pilot-program-guidances-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-21234?publication_date=2020-09-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-09-25/2020-21234/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1058,"last_updated":"2026-07-27 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-09-25/pdf/2020-21234.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-21234.pdf?1600951539","publication_date":"2020-09-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/09/25/2020-21234.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-3805","supporting_documents_count":0,"docket_id":"FDA-2019-D-3805","document_id":"FDA-2019-D-3805-0068","regulation_id_number":null,"title":"The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2024-10-19T16:55:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60471,"subtype":null,"title":"The Accreditation Scheme for Conformity Assessment Pilot Program; Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability","toc_doc":"The Accreditation Scheme for Conformity Assessment Pilot Program","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}