{"abstract":"The Department of Health and Human Services (HHS or \"the Department\") issued a Notice in the Federal Register of January 15, 2021, that, among other things, identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or \"the Agency\") have reviewed the prior determination, including the record supporting it, and believe that the determination is flawed. This notice explains the basis for HHS and FDA's current view that the seven types of reserved class I devices identified in the January 15, 2021, Notice require a premarket notification, and explains why the reasoning supporting the prior determination was unsound. HHS and FDA are seeking comment on the matters discussed in this notice and will issue a future notice in the Federal Register containing a final determination regarding the class I medical gloves listed in the January 15, 2021, Notice.","action":"Notice; request for comments.","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/2021/04/16/2021-07759.html","cfr_references":[],"citation":"86 FR 20167","comment_url":null,"comments_close_on":"2021-05-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this Notice by May 17, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-Z-0025"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":8,"comment_start_date":"2021-04-16","updated_at":"2023-02-28T22:29:33.357-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2021-Z-0025-0004","allow_late_comments":null,"id":"FDA-2021-Z-0025-0004","comment_end_date":"2021-05-18","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2021-Z-0025","title":"Dual Agency - HHS Federal Register Notices (FRN) without a docket ID which includes FDA data or supported related material"}],"document_number":"2021-07759","effective_on":null,"end_page":20172,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/04/16/2021-07759.xml","html_url":"https://www.federalregister.gov/documents/2021/04/16/2021-07759/medical-devices-class-i-surgeons-and-patient-examination-gloves","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-07759?publication_date=2021-04-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-04-16/2021-07759/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":3088,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-16/pdf/2021-07759.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-07759.pdf?1618490722","publication_date":"2021-04-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/04/16/2021-07759.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":8,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2021-Z-0025","supporting_documents_count":0,"docket_id":"FDA-2021-Z-0025","document_id":"FDA-2021-Z-0025-0004","regulation_id_number":null,"title":"Dual Agency - HHS Federal Register Notices (FRN) without a docket ID which includes FDA data or supported related material","checked_regulationsdotgov_at":"2023-03-01T03:29:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20167,"subtype":null,"title":"Medical Devices; Class I Surgeon's and Patient Examination Gloves","toc_doc":"Class I Surgeon's and Patient Examination Gloves","toc_subject":"Medical Devices:\n","topics":[],"type":"Notice","volume":86}