{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.\" Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform \"in silico\" device testing or as part of software embedded in a device. This guidance provides a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The draft guidance is intended to improve the consistency and transparency of the review of computational modeling evidence. This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2021/12/23/2021-27812.html","cfr_references":[],"citation":"86 FR 72969","comment_url":null,"comments_close_on":"2022-02-22","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 22, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-D-0980"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2021-12-23","updated_at":"2023-02-28T12:34:08.596-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-0980-0002","allow_late_comments":null,"id":"FDA-2021-D-0980-0002","comment_end_date":"2022-03-25","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-D-0980","title":"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2021-27812","effective_on":null,"end_page":72971,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/12/23/2021-27812.xml","html_url":"https://www.federalregister.gov/documents/2021/12/23/2021-27812/assessing-the-credibility-of-computational-modeling-and-simulation-in-medical-device-submissions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-27812?publication_date=2021-12-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-12-23/2021-27812/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":442,"last_updated":"2026-08-26 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-12-23/pdf/2021-27812.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-27812.pdf?1640180732","publication_date":"2021-12-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/12/23/2021-27812.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-D-0980","supporting_documents_count":0,"docket_id":"FDA-2021-D-0980","document_id":"FDA-2021-D-0980-0002","regulation_id_number":null,"title":"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-11-17T22:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72969,"subtype":null,"title":"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}