{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled \"Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.\" It was developed as a special control to support the reclassification of the vascular embolization device and the neurovascular embolization device from class III (premarket approval) into class II (special controls). The draft guidance is not final nor is it in effect at this time. We are also announcing the withdrawal of the 1994 draft guidance document entitled \"Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3--Implant Model,\" dated September 12, 1994.","action":"Notice.","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/2004/02/25/04-3859.html","cfr_references":[],"citation":"69 FR 8667","comment_url":null,"comments_close_on":"2004-05-25","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft guidance by May 25, 2004.","disposition_notes":null,"docket_ids":["Docket No. 2003D-0568"],"dockets":[],"document_number":"04-3859","effective_on":null,"end_page":8668,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/02/25/04-3859.xml","html_url":"https://www.federalregister.gov/documents/2004/02/25/04-3859/draft-guidance-for-industry-and-fda-staff-on-class-ii-special-controls-guidance-document-vascular","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-3859?publication_date=2004-02-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-02-25/04-3859/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":40,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-02-25/pdf/04-3859.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-02-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/02/25/04-3859.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8667,"subtype":null,"title":"Draft Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices; Availability","toc_doc":"Cardiovascular and neurological devices; Class II special controls","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":69}