{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.\" This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devices--premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This draft guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controls--PMAs for Breakthrough Devices and PMAs for devices for small patient populations. This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2018/09/06/2018-19249.html","cfr_references":[],"citation":"83 FR 45247","comment_url":null,"comments_close_on":"2018-12-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 5, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-3130"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2018-09-06","updated_at":"2023-03-01T03:04:28.498-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3130-0001","allow_late_comments":null,"id":"FDA-2018-D-3130-0001","comment_end_date":"2018-12-06","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-3130","title":"Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2018-19249","effective_on":null,"end_page":45249,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/09/06/2018-19249.xml","html_url":"https://www.federalregister.gov/documents/2018/09/06/2018-19249/consideration-of-uncertainty-in-making-benefit-risk-determinations-in-medical-device-premarket","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-19249?publication_date=2018-09-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-09-06/2018-19249/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":475,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-09-06/pdf/2018-19249.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-19249.pdf?1536151519","publication_date":"2018-09-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/09/06/2018-19249.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-2018-D-3130","supporting_documents_count":0,"docket_id":"FDA-2018-D-3130","document_id":"FDA-2018-D-3130-0001","regulation_id_number":null,"title":"Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-03-01T08:04:27Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45247,"subtype":null,"title":"Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}