{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a document entitled \"Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle\" dated November 2007. The guidance document serves as the special control for the automated blood cell separator device operating on a centrifugal or filtration separation principle intended for the routine collection of blood and blood components, and describes a means by which the device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify the automated blood cell separator device operating by centrifugal separation principle into class II (special controls).","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/2007/11/30/E7-23281.html","cfr_references":[],"citation":"72 FR 67736","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. 2005D-0019"],"dockets":[],"document_number":"E7-23281","effective_on":null,"end_page":67736,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/11/30/E7-23281.xml","html_url":"https://www.federalregister.gov/documents/2007/11/30/E7-23281/guidance-for-industry-and-food-and-drug-administration-staff-class-ii-special-controls-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E7-23281?publication_date=2007-11-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-11-30/E7-23281/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":37,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-11-30/pdf/E7-23281.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-11-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/11/30/E7-23281.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-13T11:12:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67736,"subtype":null,"title":"Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability","toc_doc":"Automated blood cell separator device; Class II special controls","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":72}