{"abstract":"The Food and Drug Administration (FDA) is classifying the corneal storage medium with preservatives including antifungals into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the corneal storage medium with preservatives including antifungals. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","action":"Final amendment; final order.","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/2026/05/06/2026-08813.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"886","title":21}],"citation":"91 FR 24346","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective May 6, 2026. The classification was applicable on May 2, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-4645"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-05-06","updated_at":"2026-05-06T15:13:58.341-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-4645-0001","allow_late_comments":false,"id":"FDA-2026-N-4645-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-4645","title":"Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals"}],"document_number":"2026-08813","effective_on":"2026-05-06","end_page":24348,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/06/2026-08813.xml","html_url":"https://www.federalregister.gov/documents/2026/05/06/2026-08813/medical-devices-ophthalmic-devices-classification-of-the-corneal-storage-medium-with-preservatives","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-08813?publication_date=2026-05-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-06/2026-08813/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":435,"last_updated":"2026-06-24 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-06/pdf/2026-08813.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08813.pdf?1777985115","publication_date":"2026-05-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/06/2026-08813.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-2026-N-4645","supporting_documents_count":0,"docket_id":"FDA-2026-N-4645","document_id":"FDA-2026-N-4645-0001","regulation_id_number":null,"title":"Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals","checked_regulationsdotgov_at":"2026-05-07T10:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24346,"subtype":null,"title":"Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals","toc_doc":"Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals","toc_subject":"Medical Devices","topics":["Medical devices","Ophthalmic goods and services"],"type":"Rule","volume":91}