{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Acceptance Review for De Novo Classification Requests.\" The purpose of this draft guidance is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review. This draft guidance discusses De Novo acceptance review policies and procedures, \"Refuse to Accept\" principles, and the elements of the De Novo Acceptance Checklist and the Recommended Content Checklist and is being issued to be responsive to an explicit deliverable identified in the Medical Device User Fee Amendments of 2017 (MDUFA IV). This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2017/10/30/2017-23500.html","cfr_references":[],"citation":"82 FR 50135","comment_url":null,"comments_close_on":"2017-12-29","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 29, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2017-D-6069"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2017-10-30","updated_at":"2023-02-28T15:17:59.378-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2017-D-6069-0001","allow_late_comments":null,"id":"FDA-2017-D-6069-0001","comment_end_date":"2017-12-30","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2017-D-6069","title":"Acceptance Review for De Novo Classification Requests"}],"document_number":"2017-23500","effective_on":null,"end_page":50138,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/10/30/2017-23500.xml","html_url":"https://www.federalregister.gov/documents/2017/10/30/2017-23500/acceptance-review-for-de-novo-classification-requests-draft-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-23500?publication_date=2017-10-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-10-30/2017-23500/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":311,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-10-30/pdf/2017-23500.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-23500.pdf?1509108348","publication_date":"2017-10-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/10/30/2017-23500.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-D-6069","supporting_documents_count":0,"docket_id":"FDA-2017-D-6069","document_id":"FDA-2017-D-6069-0001","regulation_id_number":null,"title":"Acceptance Review for De Novo Classification Requests","checked_regulationsdotgov_at":"2023-02-28T20:17:58Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50135,"subtype":null,"title":"Acceptance Review for De Novo Classification Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Acceptance Review for De Novo Classification Requests","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}