{"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, proposed to exempt 83 class II devices and 1 unclassified device from premarket notification. This Notice announces HHS's and the Food and Drug Administration's (FDA or \"the Agency\") withdrawal of the proposed exemptions for the 83 class II devices and 1 unclassified device. The comment period for the proposed class II and unclassified device exemptions closed on March 15, 2021. HHS and FDA are withdrawing the proposed exemptions after reviewing the Notice, its comments, inquiries to FDA, and other relevant information, and determining that the proposed exemptions and bases for them are flawed.","action":"Notice of withdrawal.","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/2021/04/16/2021-07760.html","cfr_references":[],"citation":"86 FR 20174","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The proposed exemptions of 83 class II devices and 1 unclassified device, published on January 15, 2021 (86 FR 4088), are withdrawn as of April 16, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2021-Z-0025"],"dockets":[],"document_number":"2021-07760","effective_on":null,"end_page":20177,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/04/16/2021-07760.xml","html_url":"https://www.federalregister.gov/documents/2021/04/16/2021-07760/making-permanent-regulatory-flexibilities-provided-during-the-covid-19-public-health-emergency-by","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-07760?publication_date=2021-04-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-04-16/2021-07760/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":3551,"last_updated":"2026-04-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-04-16/pdf/2021-07760.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-07760.pdf?1618490722","publication_date":"2021-04-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/04/16/2021-07760.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"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-0025-0003","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":"2021-04-17T03:30:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20174,"subtype":null,"title":"Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Withdrawal of Proposed Exemptions","toc_doc":"Making Permanent Regulatory Flexibilities Provided During the COVID19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Withdrawal of Proposed Exemptions","toc_subject":null,"topics":[],"type":"Notice","volume":86}