{"abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled \"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.\" The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","action":"Notice of availability; extension of comment period.","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/2022/01/28/2022-01788.html","cfr_references":[],"citation":"87 FR 4611","comment_url":null,"comments_close_on":"2022-03-24","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the document published December 23, 2021 (86 FR 72969). Submit either electronic or written comments on the draft guidance by March 24, 2022, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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":11,"comment_start_date":"2022-01-28","updated_at":"2023-02-28T12:30:12.337-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-D-0980-0003","allow_late_comments":null,"id":"FDA-2021-D-0980-0003","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the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff;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":"2022-01788","effective_on":null,"end_page":4612,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/01/28/2022-01788.xml","html_url":"https://www.federalregister.gov/documents/2022/01/28/2022-01788/assessing-the-credibility-of-computational-modeling-and-simulation-in-medical-device-submissions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-01788?publication_date=2022-01-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-01-28/2022-01788/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":563,"last_updated":"2026-07-28 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-01-28/pdf/2022-01788.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-01788.pdf?1643291142","publication_date":"2022-01-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/01/28/2022-01788.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":11,"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-0980-0003","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":4611,"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; Extension of Comment Period","toc_doc":"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}