{"abstract":"The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination in the Federal Register.","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/2026/05/01/2026-08499.html","cfr_references":[],"citation":"91 FR 23427","comment_url":"http://www.regulations.gov/commenton/FDA-2026-N-4268-0001","comments_close_on":"2026-06-30","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the notice must be submitted by June 30, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4268"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2026-05-01","updated_at":"2026-05-02T01:56:47.987-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-4268-0001","allow_late_comments":false,"id":"FDA-2026-N-4268-0001","comment_end_date":"2026-07-01","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2026-N-4268","title":"Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments"}],"document_number":"2026-08499","effective_on":null,"end_page":23431,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/01/2026-08499.xml","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08499/medical-devices-exemptions-from-premarket-notification-certain-class-ii-devices-request-for-comments","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-08499?publication_date=2026-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-01/2026-08499/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":922,"last_updated":"2026-05-04 10:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08499.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08499.pdf?1777553117","publication_date":"2026-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/01/2026-08499.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2026-N-4268","supporting_documents_count":0,"docket_id":"FDA-2026-N-4268","document_id":"FDA-2026-N-4268-0001","regulation_id_number":null,"title":"Medical Devices; Exemptions from Premarket Notification: Certain Class II Devices; Request for Comments","checked_regulationsdotgov_at":"2026-05-02T22:55:04Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2026-N-4268-0001","significant":null,"signing_date":null,"start_page":23427,"subtype":null,"title":"Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments","toc_doc":"Exemptions from Premarket Notification: Certain Class II Devices","toc_subject":"Medical Devices","topics":[],"type":"Notice","volume":91}